Brace, Drill
Orthopedic · 21 CFR 888.4540
Recent MDR events
44 adverse event reports on file
- TREPANBOGEN HUDSONDec 3, 2021MalfunctionAesculap Ag9610612-2021-00766
- HUDSON CHUCK F/GB102R/GB169R/GA522RSep 26, 2019InjuryAesculap Ag9610612-2019-00663
- DRILL BITSep 15, 2016MalfunctionDepuy Synthes Power Tools2520274-2016-14541
- UNI-CLIP DRILL GUIDEDec 21, 2011MalfunctionNewdeal S.a.9615741-2011-00072
- DRILL BRACE WITHOUT CHUCK ORIGINAL HOFFMANNOct 25, 2011MalfunctionStryker Osteosynthesis Selzach8031020-2011-00231
- CASPARMar 16, 2011MalfunctionAesculap2024467
- TRINICA DRILL GUIDE, ALL THROUGH ONEJul 12, 2010MalfunctionZimmer Spine2184052-2010-00022
- TRINICA ATOJul 28, 2009MalfunctionZimmer Spine, Inc.2184052-2009-00044
- TRINICA ANTERIOR CERVICAL PLATE SYSTEMDec 31, 2008MalfunctionZimmer Spine, Inc.2184052-2008-00036
- ACUFIXApr 24, 2007MalfunctionAbbott Spine1649384-2007-00022
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
92 firms currently registered for this product code
Darleys Surgical Co.
SIALKOT, PUNJAB, PK
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Teufel & Gerlach Gmbh
Tuttlingen Baden-Wurttemberg, DE
Cenova Ab
MJOLBY Ostergotland, SE
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
Exactech, Inc.
GAINESVILLE, FL, US
Arthrocare Corporation
Coyol Alajuela, CR
Shanghai Reach Medical Instrument Co., Ltd
Shanghai, CN
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Cm Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Iconn Orthopedics, Llc
Birmingham, AL, US
Kreidler Medizintechnik Gmbh
Wurmlingen Baden-Wurttemberg, DE
Surgipros Llc
Palmetto, FL, US
Seaspine Orthopedics Corporation
Carlsbad, CA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Apriomed Ab
UPPSALA, SE
Synergy Health Ede Bv
Venlo Limburg, NL
Br Surgical Llc
Jacksonville, FL, US
Narang Medical, Ltd.
New Delhi, IN
Teleflex Medical Llc
Morrisville, NC, US
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Biomet, Inc.
WARSAW, IN, US
Otto Leibinger Gmbh
MUEHLHEIM Baden-Wurttemberg, DE
Surgicon Pvt Ltd
Sialkot Punjab, PK
510(k) clearances
7 clearances for this product code
- Neimark Labs, Inc.Nov 6, 1992
K923776 · BENDEREV DRILL GUIDE
- Mitek Surgical Products, Inc.Sep 28, 1989
K892904 · MITEK DRILL GUIDE
- Orthopedic Systems, Inc.Mar 23, 1988
K880264 · BONE SUTURE FIXATION DEVICE
- Austin Assoc.Mar 15, 1988
K880381 · TELOS DISTAL TARGETING DEVICE
- Buckman Co., Inc.Feb 16, 1988
K880046 · HASTING FINGER FIXATOR INSTRUMENTS
- Orthopedic Systems, Inc.Apr 28, 1983
K831043 · ANDREWS REMOTE CHUCK DRILL
- Depuy, Inc.Feb 8, 1977
K770204 · CEMENT EXTRACTOR DRILL