The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Bioabsorbable Interference Screw System.
| Device ID | K993166 |
| 510k Number | K993166 |
| Device Name: | STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Todd Miller |
| Correspondent | Todd Miller Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-22 |
| Decision Date | 2000-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540754752 | K993166 | 000 |
| 04546540754585 | K993166 | 000 |
| 04546540754592 | K993166 | 000 |
| 04546540754608 | K993166 | 000 |
| 04546540754615 | K993166 | 000 |
| 04546540754622 | K993166 | 000 |
| 04546540754639 | K993166 | 000 |
| 04546540754738 | K993166 | 000 |
| 04546540754745 | K993166 | 000 |
| 04546540754578 | K993166 | 000 |