The following data is part of a premarket notification filed by Novatsep with the FDA for Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple.
| Device ID | K142111 |
| 510k Number | K142111 |
| Device Name: | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | NOVATSEP ESPACE PERFORMANCE ALPHASIS-BATIMENT C1-C2 Saint Gregoire, FR 35769 |
| Contact | Gilles Audic |
| Correspondent | Gilles Audic NOVATSEP ESPACE PERFORMANCE ALPHASIS-BATIMENT C1-C2 Saint Gregoire, FR 35769 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700879502366 | K142111 | 000 |
| 03700879501284 | K142111 | 000 |
| 03700879501277 | K142111 | 000 |
| 03700879501260 | K142111 | 000 |
| 03700879501253 | K142111 | 000 |
| 03700879501246 | K142111 | 000 |
| 03700879501239 | K142111 | 000 |
| 03700879500416 | K142111 | 000 |
| 03700879500409 | K142111 | 000 |
| 03700879500393 | K142111 | 000 |
| 03700879501291 | K142111 | 000 |
| 03700879501307 | K142111 | 000 |
| 03700879502359 | K142111 | 000 |
| 03700879502342 | K142111 | 000 |
| 03700879502335 | K142111 | 000 |
| 03700879502328 | K142111 | 000 |
| 03700879502311 | K142111 | 000 |
| 03700879502304 | K142111 | 000 |
| 03700879502298 | K142111 | 000 |
| 03700879501918 | K142111 | 000 |
| 03700879501314 | K142111 | 000 |
| 03700879500386 | K142111 | 000 |