Prosthesis, Wrist, Carpal Lunate
Orthopedic · 21 CFR 888.3750
Recent MDR events
20 adverse event reports on file
- UNKNOWN CARPAL BALL IMPLANTOct 9, 2020InjuryStryker Gmbh0008031020-2020-02308
- WRIST HEMIARTHROPLASTY SYSTEMJul 6, 2020InjuryArthrosurface, Inc.3004154314-2020-00003
- UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANTMar 8, 2019InjuryStryker Gmbh0008031020-2019-00156
- UNKNOWN REMOTION WRIST CARPAL IMPLANTMar 8, 2019InjuryStryker Gmbh0008031020-2019-00157
- UNKNOWN REMOTION TOTAL WRIST RADIAL IMPLANTMar 8, 2019InjuryStryker Gmbh0008031020-2019-00167
- CAPITATE STEMDec 20, 2018InjuryZimmer Biomet, Inc.0001825034-2018-11307
- MAESTRO TC CARPALHD 7X15MM STDJan 24, 2018InjuryZimmer Biomet, Inc.0001825034-2018-00335
- UNKNOWN MAESTRO WRIST RADIAL COMPONENTMar 1, 2017InjuryBiomet Orthopedics0001825034-2017-01262
- MAESTRO TOTAL WRIST TAPERED CARPAL HEAD 7MM X 15MM STANDARDDec 29, 2016InjuryBiomet Orthopedics0001825034-2016-05448
- CARPAL POLY MEDIUM - STDApr 5, 2013InjuryIntegra Lifesciences Corporation3004608878-2013-00060
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Isomedix Operations, Inc.
Libertyville, IL, US
Biomet, Inc.
WARSAW, IN, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Wright Medical Technology, Inc.
Arlington, TN, US
Arthrosurface, Inc.
W Bridgewater, MA, US
Banister Tool, Inc.
Pflugerville, TX, US
Orchid Unique
Bridgeport, MI, US
On-x Life Technologies Inc.
Austin, TX, US
Wright Medical Technology, Inc.
Arlington, TN, US
510(k) clearances
5 clearances for this product code
- Arthrosurface, Inc.Dec 23, 2014
K141920 · Wrist Hemiarthroplasty System
- Ascension Orthopedics, Inc.Jun 17, 2008
K080997 · ASCENSION PYROCARBON LUNATE
- Biomet Manufacturing, Inc.Mar 25, 2005
K050028 · MAESTRO CARPAL HEMIARTHROPLASTY
- Dow Corning WrightApr 15, 1987
K864491 · SWANSON TITANIUM CARPAL LUNATE IMPLANT
- Howmedica Corp.Jun 22, 1979
K790793 · AMC R METACARPAL COMPONENT