The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Modification To Stryker Bioabsorbable Interference Screw System.
| Device ID | K033252 |
| 510k Number | K033252 |
| Device Name: | MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-08 |
| Decision Date | 2003-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540754769 | K033252 | 000 |