Fastener, Fixation, Biodegradable, Soft Tissue
FDA product code MAI · 212 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3030
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1994-07-21 – 2026-08-07
MAI
2011-07-21
MAI
2011-03-31
ARTHREX BIOCOMPOSITE SUTURETAK
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MAI
2011-02-03
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
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MAI
2011-01-27
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
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MAI
2011-01-07
ARTHREX SWIVELOCK ANCHORS
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MAI
2011-01-05
ENDOBUTTON DIRECT
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MAI
2010-10-22
ARTHREX PUSHLOCK ANCHORS
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MAI
2010-08-26
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
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MAI
2010-04-30
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A
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MAI
2010-04-01
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
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MAI
2009-10-19
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
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MAI
2009-08-28
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
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MAI
2009-08-07
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS
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MAI
2009-06-22
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR
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MAI
2009-04-10
CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
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MAI
2009-04-03
RIGIDFIX BIOCRYL CROSS PIN KITS
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MAI
2009-03-11
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814
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MAI
2009-02-12
TORNIER, INC., INSITE SUTURE ANCHORS
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MAI
2009-01-23
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW
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MAI
2008-12-30
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
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MAI
2008-01-17
GRYPHON BR AND HEALIX BR ANCHORS
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MAI
2008-01-17
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
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MAI
2007-08-03
MODIFICATION TO: ARTHREX INTERFERENCE SCREW
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MAI
2007-05-02
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
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MAI
2007-04-30
AESCULAP RESORBABLE PIN, MODEL FR735
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MAI
2007-04-12
BIODUCT
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MAI
2006-12-19
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
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MAI
2006-11-29
ARTHREX INTERFERENCE SCREW
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MAI
2006-11-09
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
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MAI
2006-04-11
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
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MAI
2005-12-16
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
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MAI
2005-08-05
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
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MAI
2005-08-04
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
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MAI
2005-06-29
PUSHLOCK
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MAI
2005-06-09
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
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MAI
2004-11-19
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
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MAI
2004-10-05
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
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MAI
2004-07-29
SUTURE ARROW
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MAI
2004-06-14
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
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MAI
2004-06-14
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
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MAI
2004-04-30
PANALOK LOOP ANCHOR
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MAI
2003-08-08
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
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MAI
2003-07-25
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
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MAI
2003-06-06
CUFFLOK ANCHOR
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MAI
2001-11-02
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
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MAI
2001-10-29
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
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MAI
2001-10-12
BIOCUFF,C, MODELS 236018, 236028, 236036
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MAI
2001-09-19
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
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MAI
2001-08-01
ARTHREX BIO-POST AND WASHER
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MAI
2001-06-27
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
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MAI
2001-03-19
SUPER REVO SUTURE ANCHOR
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MAI
2001-02-15
MITEK 2GII MENISCAL REPAIR SYSTEM
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MAI
2001-02-09
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
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MAI
2001-01-12
CONTOUR LABRAL NAIL, MODEL 533520A
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MAI
2001-01-11
LACTOSORB SCREW ANCHOR
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MAI
2001-01-08
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
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MAI
2000-10-27
MITEK CUFFTACK
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MAI
2000-09-19
ULTRASORB SUTURE ANCHOR
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MAI
2000-08-25
LACTOSORB MENISCAL SCREW
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MAI
2000-07-28
SYNTHES BIORESORBABLE SUTURE ANCHOR
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MAI
2000-07-28
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
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MAI
2000-05-01
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
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MAI
2000-03-23
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
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MAI
2000-01-28
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
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MAI
2000-01-13
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
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MAI
2000-01-10
TITAN RC TACK
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MAI
1999-12-17
MULTITAK SS
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MAI
1999-12-10
ENDOPEARL WITH THREADER
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MAI
1999-12-10
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
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MAI
1999-12-06
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030
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MAI
1999-11-19
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
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MAI
1999-11-09
MENISCUS ARROW, MODELS 531110, 531113, 531116
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MAI
1999-10-27
ROTORBLADE SUTURE ANCHOR
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MAI
1999-09-23
ROTORBLADE SUTURE ANCHOR
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MAI
1999-08-27
ANATOMICAL BANKART TACK, MODEL 523520A
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MAI
1999-08-13
ARTHREX MENISCAL DART SYSTEM
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MAI
1999-08-06
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
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MAI
1999-06-23
RC BUTTRESS
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MAI
1999-04-29
ENDOPEARL
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MAI
1999-04-29
ROTORBLADE
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MAI
1999-04-14
MODIFICATION OF: EBI SPINELINK SYSTEM
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MAI
1999-04-14
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
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MAI
1999-03-12
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
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MAI
1999-03-01
SUTURELESS ANCHOR
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MAI
1999-01-27
LACTOSORB MENISCAL REPAIR DEVICE
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MAI
1998-10-21
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
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MAI
1998-08-31
PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
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MAI
1998-06-22
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
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MAI
1998-04-14
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
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MAI
1998-03-20
BIONX DISTAL RADIUS SCREW
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MAI
1998-02-18
BIOROC EZ SUTURE BONE FASTENER
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MAI
1998-01-06
BIOABSORBABLE BANKART TACK
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MAI
1997-11-10
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
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MAI
1997-11-03
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
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MAI
1997-07-09
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
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MAI
1997-06-09
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
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MAI
1997-06-09
BIO-ANCHOR
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MAI
1997-05-22
BIO-ANCHOR
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MAI
1997-05-06
BIOSPHERE SUTURE ANCHOR
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MAI
1997-02-24
MITEK ABSORBABLE TOGGLE ANCHOR
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