The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Peek And Titanium Soft Eyelet Anchors.
| Device ID | K071157 |
| 510k Number | K071157 |
| Device Name: | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-25 |
| Decision Date | 2007-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154890101 | K071157 | 000 |
| 07613154890095 | K071157 | 000 |
| 07613154890088 | K071157 | 000 |
| 07613154890071 | K071157 | 000 |
| 07613154644599 | K071157 | 000 |
| 07613154644582 | K071157 | 000 |
| 07613154644575 | K071157 | 000 |
| 07613154644568 | K071157 | 000 |