The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Bioabsorbable Interference Screws.
| Device ID | K984320 |
| 510k Number | K984320 |
| Device Name: | BIOABSORBABLE INTERFERENCE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Demetrios Tsakonas |
| Correspondent | Demetrios Tsakonas 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 | 1998-12-03 |
| Decision Date | 1999-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010411235 | K984320 | 000 |
| 03596010411228 | K984320 | 000 |
| 03596010390677 | K984320 | 000 |
| 03596010390653 | K984320 | 000 |
| 03596010390646 | K984320 | 000 |
| 03596010390639 | K984320 | 000 |
| 03596010390660 | K984320 | 000 |