The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Rci Fixation Screws (with Assorted Sizes).
| Device ID | K992945 |
| 510k Number | K992945 |
| Device Name: | RCI FIXATION SCREWS (WITH ASSORTED SIZES) |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Nicholas Condakes |
| Correspondent | Nicholas Condakes SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-01 |
| Decision Date | 1999-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554016253 | K992945 | 000 |
| 03596010479471 | K992945 | 000 |
| 03596010477996 | K992945 | 000 |
| 03596010477989 | K992945 | 000 |
| 03596010477972 | K992945 | 000 |
| 03596010380647 | K992945 | 000 |
| 03596010375377 | K992945 | 000 |
| 03596010375360 | K992945 | 000 |
| 03596010375353 | K992945 | 000 |
| 03596010507648 | K992945 | 000 |
| 03596010479495 | K992945 | 000 |
| 03596010479501 | K992945 | 000 |
| 00885554010565 | K992945 | 000 |
| 00885554009187 | K992945 | 000 |
| 00885554002294 | K992945 | 000 |
| 03596010479518 | K992945 | 000 |
| 03596010479488 | K992945 | 000 |
| 03596010477965 | K992945 | 000 |
| 03596010427458 | K992945 | 000 |
| 03596010427434 | K992945 | 000 |
| 03596010375346 | K992945 | 000 |
| 03596010375520 | K992945 | 000 |