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

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
Decided510(k)Device and applicantCode
Jan 18, 1989K884500ALTA NON-REAMED TIBIAL ROD
Howmedica Corp.
HSB
Dec 1, 1988K884610INTERLOCKING INTRAMEDULLARY NAILS
Depuy, Inc.
HSB
Nov 28, 1988K884407TRACER SKELETAL TRACTION PINS
De Medica Mfg., Inc.
HSB
Jun 30, 1988K882443ZINDRICK IM ROD INSTRUMENTS
Buckman Co., Inc.
HSB
Mar 14, 1988K880737SELF GUIDING (SG) INTERLOCKING NAIL
Orthopaedic Designs, Inc.
HSB
Aug 17, 1987K871539ZINDRICK IM ROD
Buckman Co., Inc.
HSB
Aug 5, 1987K871947MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
Downs Surgical , Ltd., GB
HSB
Jun 30, 1987K871814SARMIENTO FOREARM NAIL
Depuy, Inc.
HSB
Jun 23, 1987K871872HI MARC INTERLOCKING NAIL
Depuy, Inc.
HSB
May 8, 1987K871608RODRIGUEZ NAIL
Richards Medical Co., Inc.
HSB
Mar 26, 1987K870040INTRAMEDULLARY NAIL
The Deca Co.
HSB
May 6, 1986K861365FASICULATED NAIL
Lake Region Mfg., Inc.
HSB
Mar 28, 1986K860756GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
Howmedica Corp.
HSB
Mar 19, 1986K860592ACE IM ROD
Buckman Co., Inc.
HSB
Feb 12, 1986K853250FEMOROTIBIAL MEDULLARY NAIL
Zimmer, Inc.
HSB
Feb 4, 1986K854227FASCILULATED NAIL
The Deca Co.
HSB
Dec 9, 1985K854338KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
Kirschner Medical Corp.
HSB
May 22, 1985K852020INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
Warsaw Orthopedic, Inc.
HSB
Apr 19, 1985K850441MEC INTRAMEDULLARY ROD
Pfizer, Inc.
HSB
Feb 7, 1985K850142ACE INTRAMEDULLARY ROD FOR SMALL BONES
Buckman Co., Inc.
HSB
Mar 1, 1983K830087INTRAMEDULLARY ROD
The Deca Co.
HSB
Apr 15, 1982K820852MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
Serrano Intl.
HSB
Mar 1, 1982K813371GROSSE AND KEMPF LOCKING NAIL SYS.
Howmedica Corp.
HSB
Apr 29, 1981K811002ENDER PINS
Richard'S Medical Equip., Inc.
HSB
Apr 17, 1981K810957MARCOVE INTRAMEDULLARY ROD
Hexcel Medical
HSB
Apr 17, 1981K810956MARCOVE HUMERAL ROD
Hexcel Medical
HSB
Mar 13, 1981K810535MOURADIAN MODIFIED ZICKEL HUMERAL ROD
Howmedica Corp.
HSB
Feb 12, 1981K803106AGINSKY NAIL
Cintor Orthopaedic Div.
HSB
Feb 9, 1981K803196FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM
Howmedica Corp.
HSB
May 20, 1980K801010KIRSCHNER WIRE
American Safety Equipment Corp.
HSB
Dec 5, 1979K792203CURVED KUNTSCHER INTRAMEDULLARY NAIL
Howmedica Corp.
HSB
Nov 11, 1977K772081NAIL, INTRAMEDULLARY, FLEXIBLE
Depuy, Inc.
HSB

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