The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Biosure Regenesorb Interference Screw.
| Device ID | K142948 |
| 510k Number | K142948 |
| Device Name: | BIOSURE REGENESORB Interference Screw |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Smith & Nephew, Inc 150 Minuteman Dr Andover, MA 01810 |
| Contact | Vivek Mukhatyar |
| Correspondent | Vivek Mukhatyar Smith & Nephew, Inc 150 Minuteman Dr Andover, MA 01810 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2015-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554037463 | K142948 | 000 |
| 00885554036763 | K142948 | 000 |
| 00885554036756 | K142948 | 000 |
| 00885554036749 | K142948 | 000 |
| 00885554036732 | K142948 | 000 |
| 00885554036725 | K142948 | 000 |
| 00885554036718 | K142948 | 000 |
| 00885554036701 | K142948 | 000 |
| 00885554036695 | K142948 | 000 |
| 00885554036688 | K142948 | 000 |
| 00885554036671 | K142948 | 000 |
| 00885554036664 | K142948 | 000 |
| 00885554036770 | K142948 | 000 |
| 00885554036787 | K142948 | 000 |
| 00885554036794 | K142948 | 000 |
| 00885554036909 | K142948 | 000 |
| 00885554036893 | K142948 | 000 |
| 00885554036886 | K142948 | 000 |
| 00885554036879 | K142948 | 000 |
| 00885554036862 | K142948 | 000 |
| 00885554036855 | K142948 | 000 |
| 00885554036848 | K142948 | 000 |
| 00885554036831 | K142948 | 000 |
| 00885554036824 | K142948 | 000 |
| 00885554036817 | K142948 | 000 |
| 00885554036800 | K142948 | 000 |
| 00885554036572 | K142948 | 000 |