ClearanceBrief
Panels › Orthopedic › Product code JDR · Class 2

Staple, Fixation, Bone

Regulation 888.3030

2510(k)s in 12 months (233 all time)
2recalls in 12 months (37 all time)
35recalls that name a 510(k)
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Top companies in JDR

Company510(k)sRecalls
Mitek Surgical Products, Inc.160
Smith & Nephew Inc., Endoscopy Division29
Acufex Microsurgical, Inc.90
Biomet, Inc.36
Depuy Mitek, A Johnson & Johnson Company71
Synthes (USA) Products, LLC25
Arthrex, Inc.60
Biomedical Ent., Inc.60
In2bones Sas42
Howmedica Corp.50
Decided510(k)Device and applicantCode
May 29, 1991K911020LIGAMENTOPLASTIC STAPLE OF L'UNION
Sport Service, Inc.
JDR
Mar 12, 1991K910723BIODEGRADABLE SURGICAL STAPLE
Instrument Makar, Inc.
JDR
Jan 4, 1991K905112SNAP-PAK (TM)
Mitek Surgical Products, Inc.
JDR
Dec 21, 1990K904553BONE STAPLE(S)
Synthes (Usa)
JDR
Dec 11, 1990K905364ROUND STAPLE
O'Tec Corp.
JDR
Dec 11, 1990K905363FIXATION STAPLE
O'Tec Corp.
JDR
Dec 11, 1990K905362BARBED SQUARE STAPLE
O'Tec Corp.
JDR
Oct 19, 1990K904340FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
Neoligaments, Ltd.
JDR
Aug 9, 1990K903022FIXATION STAPLE
Onyx Medical Corp.
JDR
Jul 30, 1990K903273BARBED SQUARE STAPLE
Onyx Medical Corp.
JDR
Jul 30, 1990K903271ROUND STAPLE
Onyx Medical Corp.
JDR
Jul 24, 1990K902751MITEK ANCHOR II
Mitek Surgical Products, Inc.
JDR
Jul 24, 1990K896471TENSTAPLE ORTHOPEDIC STAPLING SYSTEM
Tenstaple, Inc.
JDR
Jul 10, 1990K902567STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES
A. Henniss
JDR
May 9, 1990K895117HTO COMPRESSING STAPLE
Howmedica Corp.
JDR
Apr 4, 1990K897155MITEK ANCHOR(TM)
Mitek Surgical Products, Inc.
JDR
Apr 4, 1990K893203BONE SCREW
Karlin Technology, Inc.
JDR
Sep 19, 1989K892126MITEK ANCHOR
Mitek Surgical Products, Inc.
JDR
Aug 30, 1989K894929STAPLE FIXATION SYSTEM
Concept, Inc.
JDR
May 15, 1989K890962ORTHOPAEDIC STAPLES
Ortho Spectrum, Inc.
JDR
Feb 4, 1988K874914ORTHOMET ORTHOPEDIC STAPLES
Orthomet, Inc.
JDR
Sep 16, 1987K873507LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM
Link America, Inc.
JDR
Apr 17, 1986K861137ORTHOMED ORTHOPAEDIC FIXATION STAPLES
Biomedical Exports, Inc.
JDR
Jan 21, 1986K853704LINK DYNAMIC STAPLE
Link America, Inc.
JDR
Nov 19, 1985K854445KIRSCHNER BONE FIXATION FASTENER SYSTEM
Kirschner Medical Corp.
JDR
Sep 6, 1985K853267DAY STAPLE
Protek, Inc.
JDR
Nov 23, 1984K840566BONE STAPLING FIXATION SYS
3M Company
JDR
Oct 20, 1983K832884FIXATION STAPLE DRIVER/EXTRACTOR
Warsaw Orthopedic, Inc.
JDR
Mar 9, 1983K830455STAPLES DESIGNED FOR ARTHROSCOPIC SURG
Instrument Makar, Inc.
JDR
Oct 27, 1982K822943ELLISON VITALLIUM FIXATION STAPLE SYS
Howmedica Corp.
JDR
Jan 12, 1982K813567TECHMEDIA BONE STAPLE
Techmedica, Inc.
JDR
Jun 18, 1981K811500COLBALT ALLOY ORTHOPAEDIC WIRE
Osteonics Corp.
JDR
Dec 5, 1979K792204HOWMEDICA COMPRESSION STAPLE SYSTEM
Howmedica Corp.
JDR

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