NDGClass IIImplant
Washer, Bolt, Nut, Non-spinal, Metallic
Orthopedic · 21 CFR 888.3030
MDR events7All time
Recalls1All time
Registered firms38Currently listed
510(k) clearances1All time
Recent MDR events
7 adverse event reports on file
- SMART TSF WIRE COMBI BOLTFeb 13, 2025MalfunctionSmith & Nephew, Inc.1020279-2025-00273
- SMART TSF WIRE COMBI BOLTMar 7, 2024MalfunctionSmith & Nephew, Inc.1020279-2024-00506
- WASHER, BOLT, NUT, NON-SPINAL CETALLICJul 23, 2019InjuryWrights Lane Synthes Usa Products Llc2939274-2019-59329
- WASHER, BOLT, NUT, NON-SPINAL, CETALLICSep 12, 2017InjurySynthes Usa2520274-2017-12257
- WASHER, BOLT, NUT, NON-SPINAL, CETALLICMay 18, 2017InjurySynthes (usa)2520274-2017-11669
- WASHER, BOLT, NUT, NON-SPINAL,CETALLICAug 4, 2016InjurySynthes Usa2520274-2016-13916
- Unnamed deviceSep 16, 2013InjurySynthes Usa2520274-2013-01184
Event type breakdown
Injury5
Malfunction2
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
38 firms currently registered for this product code
Trimed, Inc.
Santa Clarita, CA, US
Smith And Nephew Operations Sdn. Bhd
Penang Pulau Pinang, MY
Smith & Nephew, Inc.
Memphis, TN, US
Quadm Technologies, Llc
Hamilton, NJ, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Jeil Medical Corporation
Seoul, KR
Smith & Nephew, Inc.
Memphis, TN, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Depuy Synthes Sales
Bridgewater, MA, US
Veritas Medical Devices Llc
Southlake, TX, US
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Zimmer, Inc.
WARSAW, IN, US
510(k) clearances
1 clearances for this product code