The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Biozip Suture Anchor.
| Device ID | K023192 |
| 510k Number | K023192 |
| Device Name: | STRYKER BIOZIP SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Alisa Miller |
| Correspondent | Alisa Miller Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613154470885 | K023192 | 000 |
| 34546540392467 | K023192 | 000 |