Rod, Fixation, Intramedullary And Accessories
FDA product code HSB · 490 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3020
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-11-11 – 2026-09-24
HSB
2011-06-22
HSB
2011-05-03
PICCOLO COMPOSITE NAILING SYSTEM
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HSB
2011-03-23
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
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HSB
2011-03-04
OLECRA INTRAMEDULLARY FIXATION SYSTEM
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HSB
2011-03-02
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
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HSB
2011-01-31
PICCOLO COMPOSITE NAILING SYSTEM
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HSB
2011-01-19
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
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HSB
2010-12-22
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
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HSB
2010-10-07
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
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HSB
2010-10-01
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
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HSB
2010-09-28
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
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HSB
2010-07-12
ASCENSION ANKLE FUSION NAIL SYSTEM
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HSB
2010-06-29
WRIST ARTHRODESIS NAIL SYSTEM
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HSB
2010-06-23
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
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HSB
2010-06-21
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
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HSB
2010-06-17
T2 GREATER TROCHANTER NAIL
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HSB
2010-05-11
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
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HSB
2010-04-26
SURESHOT TAN NAILS AND ACCESSORIES
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HSB
2010-04-20
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
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HSB
2010-01-21
QUANTUM M COMPOSITE NAILING SYSTEM
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HSB
2010-01-20
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
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HSB
2009-12-02
DYNA LOCKING IM NAIL
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HSB
2009-11-13
MAGNUM NAIL
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HSB
2009-11-05
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
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HSB
2009-10-28
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
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HSB
2009-09-25
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
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HSB
2009-08-17
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
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HSB
2009-07-29
PANTA NAIL (DIA. 10MM), PANTA NAIL XL
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HSB
2009-07-14
VALOR ANKLE FUSION NAIL SYSTEM
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HSB
2009-06-30
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
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HSB
2009-06-17
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
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HSB
2009-05-14
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
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HSB
2009-03-26
AOS PROXIMAL HUMERAL NAIL
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HSB
2009-03-11
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
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HSB
2009-02-19
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
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HSB
2009-02-09
INTRAMEDULLARY FIXATION ROD (IFS)
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HSB
2009-02-01
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
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HSB
2009-01-27
AEQUALIS HUMERAL NAIL SYSTEM
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HSB
2009-01-13
TRAUSON INTRAMEDULLARY NAIL
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HSB
2008-12-18
MODIFICATION TO T2 RECON NAIL SYSTEM
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HSB
2008-12-11
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
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HSB
2008-10-10
T2 FLEXIBLE NAIL
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HSB
2008-10-10
ENSPLINTCMX CLAVICLE PIN
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HSB
2008-08-11
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
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HSB
2008-07-18
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
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HSB
2008-07-09
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
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HSB
2008-06-27
BIOMET PHOENIX ANKLE NAIL SYSTEM
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HSB
2008-06-10
T2 FEMORAL NAIL
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HSB
2008-02-29
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
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HSB
2008-02-07
SANATMETAL NAILS AND PINS
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HSB
2007-12-17
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
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HSB
2007-10-12
ACID ETCHED LAG SCREWS
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HSB
2007-09-20
BIOMET FEMORAL LOCKING NAIL SYSTEM
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HSB
2007-08-09
ACUMED SMALL BONE LOCKING SYSTEM II
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HSB
2007-06-14
AOS TIBIAL NAIL
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HSB
2007-05-02
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
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HSB
2007-03-01
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
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HSB
2007-02-27
BIOMET TIBIAL LOCKING NAIL SYSTEM
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HSB
2006-12-27
METAIZEAU NAILING SYSTEM
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HSB
2006-09-21
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
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HSB
2006-06-16
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM
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HSB
2006-04-13
S2 RECON NAIL SYSTEM
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HSB
2005-12-12
ORTHOFIX TITANIUM NAILING SYSTEMS
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HSB
2005-12-02
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
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HSB
2005-09-21
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
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HSB
2005-08-22
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL
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HSB
2005-07-29
T2 ANKLE ARTHRODESIS NAIL
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HSB
2005-07-07
T2 RECON NAIL SYSTEM
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HSB
2005-05-27
NEWDEAL ANKLE NAIL
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HSB
2005-03-14
AOS HUMERAL NAIL
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HSB
2005-02-16
EBI TROCHANTERIC NAIL SYSTEM
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HSB
2005-02-16
GAMMA3 NAIL SYSTEM
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HSB
2005-02-03
SIGN FIN NAIL
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HSB
2005-02-01
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
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HSB
2005-01-31
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
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HSB
2004-12-27
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
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HSB
2004-12-02
MODULAR ARTHRODESIS NAIL
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HSB
2004-11-24
TRIGEN HINDFOOT FUSION NAIL
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HSB
2004-10-08
T2 PROXIMAL HUMERAL NAIL
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HSB
2004-10-07
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
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HSB
2004-10-07
TITANIUM TELEGRAPH HUMERAL NAIL
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HSB
2004-10-07
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
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HSB
2004-09-08
TROCHANTERIC NAIL SYSTEM
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HSB
2004-08-17
FASSIER-DUVAL TELSCOPIC IM SYSTEM
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HSB
2004-05-25
TRIGEN ADOLESCENT TAN
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HSB
2004-04-12
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
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HSB
2004-03-23
TRIGEN TROCHANTERIC ANTEGRADE NAIL
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HSB
2004-02-20
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
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HSB
2004-02-20
ACE PROXIMAL HUMERAL NAIL SYSTEM
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HSB
2004-02-05
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
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HSB
2004-01-15
GAMMA3 NAIL SYSTEM
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HSB
2004-01-12
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
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HSB
2003-12-03
MODIFICATION TO TELEGRAPH HUMERAL NAIL
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HSB
2003-11-14
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
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HSB
2003-10-22
T2 NAILING SYSTEM
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HSB
2003-10-09
T2 RECON NAIL SYSTEM
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HSB
2003-10-01
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
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HSB
2003-09-12
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
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HSB
2003-09-10
IP-XS COMPRESSION NAIL SYSTEM
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HSB
2003-08-29
S2 NAIL SYSTEM
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