ClearanceBrief
Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

Decided510(k)Device and applicantCode
Sep 22, 1999K992350PYLON INTRAMEDULLAARY NAIL SYSTEM
Alphatec Mfg., Inc.
HSB
Sep 3, 1999K992063OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
Howmedica Osteonics Corp.
HSB
Aug 6, 1999K991790ULTIMAX ANKLE FUSION ROD SYSTEM
Encore Orthopedics, Inc.
HSB
Jun 2, 1999K990717FIXION INTRAMEDULLARY NAILING SYSTEM
Disco-O-Tech Medical Technologies, Ltd.
HSB
Apr 1, 1999K990322PERRY HUMERAL NAIL
Pioneer Surgical Technology
HSB
Mar 31, 1999K990436ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB
Mar 15, 1999K990152OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
Howmedica Osteonics Corp.
HSB
Mar 5, 1999K984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
Syntec Scientific Corp., TW
HSB
Mar 1, 1999K984543SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
Syntec Scientific Corp., TW
HSB
Feb 1, 1999K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
Depuy Ace Medical Co.
HSB
Feb 1, 1999K984305ZETA MULTIZONE LOCKING NAIL SYSTEM
Howmedica, Inc.
HSB
Dec 16, 1998K984353OSTEO 9MM IC TIBIAL NAIL
Osteonics Corp.
HSB
Dec 4, 1998K983641HOLLAND FEMORAL NAIL SYSTEM
Biomet, Inc.
HSB
Nov 20, 1998K982958ZETA MULTIZONE LOCKING NAIL SYSTEM
Howmedica Corp.
HSB
Nov 18, 1998K983358G/K SFN AND STN LOCKING NAILS
Howmedica, Inc.
HSB
Oct 27, 1998K983339OSTEO DYNATROC PROXIMAL FEMORAL NAIL
Osteonics Corp.
HSB
Oct 21, 1998K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
Biomet, Inc.
HSB
Oct 21, 1998K982873ZETA MULTIZONE SCN LOCKING NAIL
Howmedica Corp.
HSB
Sep 14, 1998K982602RETROGRADE ROD SYSTEM
Howmedica Corp.
HSB
Sep 14, 1998K982601OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
Osteonics Corp.
HSB
Jun 22, 1998K981309OSTEO I-C HUMERAL NAIL SYSTEM
Osteonics Corp.
HSB
Jun 22, 1998K981261HOWMEDICA SCN NAIL
Howmedica Corp.
HSB
Jun 1, 1998K981230ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB
May 18, 1998K980609SEGMENTAL DEFECT REPLACEMENT SYSTEM
Metagen, LLC
HSB
Apr 3, 1998K980102BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB
Mar 13, 1998K974720HOWMEDICA(R) FULLY THREADED SCREWS
Howmedica, Inc.
HSB
Mar 10, 1998K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
Depuy, Inc.
HSB
Dec 19, 1997K973944ORTHOFIX FEMORAL NAILING SYTEM
Orthofix Srl
HSB
Oct 9, 1997K972813GAMMA LOCKING NAIL SYSTEM
Howmedica Corp.
HSB
Oct 6, 1997K972811HOWMEDICA FULLY THREADED SCREWS
Howmedica Corp.
HSB
Oct 3, 1997K971056MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
Wrightmedicaltechnologyinc
HSB
Sep 19, 1997K972692MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
Zimmer, Inc.
HSB
Aug 26, 1997K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
Ace Medical Co.
HSB
Aug 12, 1997K972108ALTA INTRAMEDULLARY ROD SYSTEM
Howmedica Corp.
HSB
Aug 11, 1997K964444QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
Rdh Medical
HSB
Jul 18, 1997K971816ATLAS FRACTURE PROXIMAL HUMERAL NAIL
Biomet, Inc.
HSB
Jun 5, 1997K971135MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
Wrightmedicaltechnologyinc
HSB
May 22, 1997K970280FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
Ferguson Medical
HSB
May 22, 1997K970257FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
Ferguson Medical
HSB
Apr 21, 1997K970897BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB
Mar 21, 1997K970202DEPUY ACE AIM TITANIUM TIBIAL NAIL
Depuy Ace Medical Co.
HSB
Mar 13, 1997K961360TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
Encore Orthopedics, Inc.
HSB
Feb 28, 1997K965098INTRAMEDULLARY NAIL SYSTEM
Zimmer, Inc.
HSB
Dec 27, 1996K964163TRIMAX NAIL SYSTEM
Smith & Nephew Richards, Inc.
HSB
Dec 5, 1996K964243HUMERUS WIRES
Compagnie Financiere & Medicale (Cf&M), FR
HSB
Oct 28, 1996K963026TBD
Acu Med, Inc.
HSB
Oct 1, 1996K963077TBD
Acu Med, Inc.
HSB
Sep 25, 1996K962561SUPRACONDYLAR INTRAMEDULLARY NAIL
Zimmer, Inc.
HSB
Sep 25, 1996K962552EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB
Aug 28, 1996K962553EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
Biodynamic Technologies, Inc.
HSB

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