The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw And Spiked Washer System.
| Device ID | K994202 |
| 510k Number | K994202 |
| Device Name: | ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM |
| 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 | 1999-12-13 |
| Decision Date | 2000-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556468340 | K994202 | 000 |
| 03596010650658 | K994202 | 000 |
| 03596010650566 | K994202 | 000 |
| 03596010471376 | K994202 | 000 |
| 03596010464675 | K994202 | 000 |
| 03596010460608 | K994202 | 000 |