The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Osteoraptor Suture Anchor.
| Device ID | K082215 |
| 510k Number | K082215 |
| Device Name: | OSTEORAPTOR SUTURE ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Julie Acker |
| Correspondent | Julie Acker SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | JDR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2008-11-03 |
| Summary: | summary |