The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Smith & Nephew Peek Interference Screw.
| Device ID | K083226 |
| 510k Number | K083226 |
| Device Name: | SMITH & NEPHEW PEEK INTERFERENCE SCREW |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Contact | Kathy Reddig |
| Correspondent | Kathy Reddig SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010645241 | K083226 | 000 |
| 03596010620842 | K083226 | 000 |
| 03596010620859 | K083226 | 000 |
| 03596010620866 | K083226 | 000 |
| 03596010620873 | K083226 | 000 |
| 03596010620880 | K083226 | 000 |
| 03596010621511 | K083226 | 000 |
| 03596010621528 | K083226 | 000 |
| 03596010621535 | K083226 | 000 |
| 03596010645227 | K083226 | 000 |
| 03596010645234 | K083226 | 000 |
| 03596010001856 | K083226 | 000 |