Novosource, LLC
FDA Regulatory Profile
Novosource, LLC appears in FDA public data with 1 recall, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0483-2025, Class II) was initiated on September 19, 2024. Its most recent 510(k) clearance was granted on April 27, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0483-2025 | Class II | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip Syste | September 19, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261032 | NovoKnee (SteriKnee) | April 27, 2026 |
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG | June 27, 2014 |
| K132158 | NOVOHIP TOTAL HIP SYSTEM | February 21, 2014 |
| K131398 | NOVOKNEE TOTAL KNEE SYSTEM | September 16, 2013 |
| K123339 | TK1 TOTAL KNEE SYSTEM | April 11, 2013 |