The following data is part of a premarket notification filed by Stryker Corp. with the FDA for 3.9mm Reelx Stt Suture Anchor System.
| Device ID | K120824 |
| 510k Number | K120824 |
| Device Name: | 3.9MM REELX STT SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | STRYKER CORP. 3201 E. 3RD AVE Denver, CO 80206 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk STRYKER CORP. 3201 E. 3RD AVE Denver, CO 80206 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613252592809 | K120824 | 000 |