Skeletal Dynamics, Inc
7300 N Kendall Drive, Miami, FL, US
Registered product codes
17 product codes
Recent MDR events
72 on file
- Skeletal DynamicsJul 31, 2026Malfunction3006742481-2026-00015
- Skeletal DynamicsJul 31, 2026Injury3006742481-2026-00013
- Skeletal DynamicsJul 30, 2026Injury3006742481-2026-00014
- STABLYX CMC ARTHROPLASTY SYSTEMJul 16, 2026InjuryMW5190813
- SKELETAL DYNAMICSJun 12, 2026Malfunction3006742481-2026-00012
- SKELETAL DYNAMICS INC.Jun 3, 2026Injury3006742481-2026-00010
- SKELETAL DYNAMICS INC.Jun 3, 2026Malfunction3006742481-2026-00009
- SKELETAL DYNAMICS INC.May 20, 2026Injury3006742481-2026-00008
- SKELETAL DYNAMICS INC.May 19, 2026Injury3006742481-2026-00006
- SKELETAL DYNAMICS INC.May 19, 2026Injury3006742481-2026-00005
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3006742481.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 5, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 5, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.40(a)Not approved or obsolete document retrieval
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
121 CFR 820.184Lack of or inadequate DHR procedures
1
- 21 CFR 820.40(a)Apr 5, 2024
Not approved or obsolete document retrieval
- 21 CFR 820.50Apr 5, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Apr 5, 2024
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.80(b)Apr 5, 2024
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Apr 5, 2024
Lack of or inadequate DHR procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.