The following data is part of a premarket notification filed by Ortho-pro Llc with the FDA for Sts Screw.
| Device ID | K032682 |
| 510k Number | K032682 |
| Device Name: | STS SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420169518 | K032682 | 000 |
| 00840420169501 | K032682 | 000 |
| 00840420169495 | K032682 | 000 |
| 00840420169488 | K032682 | 000 |
| 00840420169471 | K032682 | 000 |
| 00840420169426 | K032682 | 000 |
| 00840420169419 | K032682 | 000 |
| 00840420169402 | K032682 | 000 |