KWGClass IIIImplant
Prosthesis, Finger, Constrained, Metal/polymer
Orthopedic · 21 CFR 888.3220
Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
MDR events18All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances0All time
Recent MDR events
18 adverse event reports on file
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00019
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00016
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00018
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00017
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00015
- AE-QAS-SP42Mar 4, 2024InjuryAesculap Ag2916714-2024-00020
- UNSPECIFIED OZARK SCREWJun 9, 2022MalfunctionK2m, Inc.3004774118-2022-00222
- UNSPECIFIED OZARK SCREWJun 9, 2022MalfunctionK2m, Inc.3004774118-2022-00224
- UNSPECIFIED OZARK SCREWJun 9, 2022MalfunctionK2m, Inc.3004774118-2022-00223
- C8402, M ALEXIS O WND PROT/RET 5/BXDec 13, 2019MalfunctionApplied Medical Resources2027111-2019-00665
Event type breakdown
Injury11
Malfunction7
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.