The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Peek Twinloop Tac.
| Device ID | K070882 |
| 510k Number | K070882 |
| Device Name: | STRYKER PEEK TWINLOOP TAC |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Jeff Semone |
| Correspondent | Jeff Semone Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | MBI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-07-20 |
| Summary: | summary |