The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Biorci Screw.
| Device ID | K032224 |
| 510k Number | K032224 |
| Device Name: | BIORCI SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Marion W Gordon |
| Correspondent | Marion W Gordon SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010485618 | K032224 | 000 |
| 03596010485601 | K032224 | 000 |
| 03596010485595 | K032224 | 000 |
| 03596010485588 | K032224 | 000 |
| 03596010485564 | K032224 | 000 |
| 03596010485557 | K032224 | 000 |
| 03596010485540 | K032224 | 000 |
| 03596010435477 | K032224 | 000 |
| 03596010000897 | K032224 | 000 |