Company ยท US
Novosource, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2026 | K261032 | NovoKnee (SteriKnee) NovoSource | JWH |
| Jun 27, 2014 | K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG Novosource, Inc. | OQG |
| Feb 21, 2014 | K132158 | NOVOHIP TOTAL HIP SYSTEM Novosource, Inc. | LPH |
| Sep 16, 2013 | K131398 | NOVOKNEE TOTAL KNEE SYSTEM Novosource, Inc. | JWH |
| Apr 11, 2013 | K123339 | TK1 TOTAL KNEE SYSTEM Novosource, Inc. | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2024 | Novosource, LLC NovoHip Biolox Ball Head 32mmL
Ref: 1345-2803
NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including fem Open, Classified |
LPH | K132158 |