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
2003-08-12
HSB
2003-08-08
GAMMA 3 NAIL SYSTEM
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HSB
2003-08-08
DEPUY ACE VERSANAIL TIBIAL NAIL
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HSB
2003-07-17
ACUMED SMALL BONE LOCKING ROD SYSTEM II
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HSB
2003-05-28
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
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HSB
2003-02-06
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
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HSB
2002-12-24
TELEGRAPH HUMERAL NAIL
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HSB
2002-12-18
ACE VERSANAIL
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HSB
2002-12-11
T2 SUPRACONDYLAR NAIL SYSTEM
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HSB
2002-11-14
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
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HSB
2002-09-23
SIGN IM NAIL
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HSB
2002-08-26
S2 TIBIAL NAIL
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HSB
2002-08-26
TITANIUM ANKLE ARTHRODESIS NAIL
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HSB
2002-08-22
S2 FEMORAL NAIL
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HSB
2002-07-25
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
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HSB
2002-06-26
T2 FEMORAL NAIL
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HSB
2002-06-20
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
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HSB
2002-05-24
G4 SLEEVED NAIL
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HSB
2002-05-23
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
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HSB
2002-05-16
APEX INTRAMEDULLARY NAIL SYSTEM
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HSB
2002-05-06
T2 ARTHRODESIS NAIL SYSTEM
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HSB
2002-04-25
S2 TIBIAL NAIL
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HSB
2002-04-25
S2 FEMORAL NAIL
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HSB
2002-04-04
LONG LENGTH GAMMA NAIL
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HSB
2002-03-29
GAMMA 3 LAG SCREW
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HSB
2002-02-25
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
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HSB
2002-01-25
T2 FEMORAL NAIL SYSTEM
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HSB
2001-12-27
LONG TROCHANTERIC NAIL SYSTEM
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HSB
2001-12-20
SIGN IM NAIL
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HSB
2001-12-19
POLARUS CAP SCREW
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HSB
2001-12-19
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
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HSB
2001-12-17
ACE BIO WIN TIBIAL NAILING SYSTEM
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HSB
2001-11-16
LONG LENGTH DYAX NAIL
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HSB
2001-11-14
TROCHANTERIC DYAX NAIL SYSTEM
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HSB
2001-10-04
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
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HSB
2001-09-24
AOS MODULAR FEMORAL NAIL
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HSB
2001-09-12
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
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HSB
2001-08-01
MODIFICATION TO: LONG LENGTH GAMMA NAIL
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HSB
2001-07-11
SIGN IM NAIL
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HSB
2001-06-19
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
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HSB
2001-06-19
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
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HSB
2001-06-15
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
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HSB
2001-06-12
T2 HUMERAL NAIL SYSTEM
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HSB
2001-06-12
TROCHANTERIC NAIL
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HSB
2001-05-02
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
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HSB
2001-04-17
WUJIN #3 FEMORAL NAIL
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HSB
2001-04-06
T2 FEMORAL NAIL
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HSB
2000-12-15
ACE AIM TTC FUSION NAIL
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HSB
2000-12-15
TITAN TIBIAL NAIL
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HSB
2000-12-05
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
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HSB
2000-10-23
BROOKER FEMORAL NAILS
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HSB
2000-10-04
BROOKER TIBIA NAILS
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HSB
2000-08-29
VECTOR TARGETING SYSTEM
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HSB
2000-03-10
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
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HSB
2000-03-10
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
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HSB
1999-12-20
TITANIUM PEDIATRIC FEMORAL NAIL
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HSB
1999-11-19
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
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HSB
1999-11-16
MODIFIED LONG LENGTH GAMMA NAIL
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HSB
1999-09-22
PYLON INTRAMEDULLAARY NAIL SYSTEM
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HSB
1999-09-03
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
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HSB
1999-08-06
ULTIMAX ANKLE FUSION ROD SYSTEM
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HSB
1999-06-02
FIXION INTRAMEDULLARY NAILING SYSTEM
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HSB
1999-04-01
PERRY HUMERAL NAIL
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HSB
1999-03-31
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
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HSB
1999-03-15
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
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HSB
1999-03-05
SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
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HSB
1999-03-01
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
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HSB
1999-02-01
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
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HSB
1999-02-01
ZETA MULTIZONE LOCKING NAIL SYSTEM
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HSB
1998-12-16
OSTEO 9MM IC TIBIAL NAIL
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HSB
1998-12-04
HOLLAND FEMORAL NAIL SYSTEM
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HSB
1998-11-20
ZETA MULTIZONE LOCKING NAIL SYSTEM
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HSB
1998-11-18
G/K SFN AND STN LOCKING NAILS
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HSB
1998-10-27
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
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HSB
1998-10-21
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
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HSB
1998-10-21
ZETA MULTIZONE SCN LOCKING NAIL
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HSB
1998-09-14
RETROGRADE ROD SYSTEM
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HSB
1998-09-14
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
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HSB
1998-06-22
OSTEO I-C HUMERAL NAIL SYSTEM
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HSB
1998-06-22
HOWMEDICA SCN NAIL
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HSB
1998-06-01
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
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HSB
1998-05-18
SEGMENTAL DEFECT REPLACEMENT SYSTEM
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HSB
1998-04-03
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
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HSB
1998-03-13
HOWMEDICA(R) FULLY THREADED SCREWS
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HSB
1998-03-10
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
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HSB
1997-12-19
ORTHOFIX FEMORAL NAILING SYTEM
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HSB
1997-10-09
GAMMA LOCKING NAIL SYSTEM
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HSB
1997-10-06
HOWMEDICA FULLY THREADED SCREWS
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HSB
1997-10-03
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
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HSB
1997-09-19
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
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HSB
1997-08-26
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
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HSB
1997-08-12
ALTA INTRAMEDULLARY ROD SYSTEM
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HSB
1997-08-11
QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
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HSB
1997-07-18
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
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HSB
1997-06-05
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
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HSB
1997-05-22
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
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HSB
1997-05-22
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
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HSB
1997-04-21
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
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HSB
1997-03-21
DEPUY ACE AIM TITANIUM TIBIAL NAIL
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HSB
1997-03-13
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
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