The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Suture Hapla Interference Screw.
| Device ID | K002274 |
| 510k Number | K002274 |
| Device Name: | SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Tedd Gosian |
| Correspondent | Tedd Gosian SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2001-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010460189 | K002274 | 000 |
| 03596010459992 | K002274 | 000 |
| 03596010459985 | K002274 | 000 |
| 03596010459978 | K002274 | 000 |
| 03596010459961 | K002274 | 000 |
| 03596010459954 | K002274 | 000 |
| 03596010459947 | K002274 | 000 |
| 03596010459930 | K002274 | 000 |
| 03596010459923 | K002274 | 000 |
| 03596010459916 | K002274 | 000 |
| 03596010460004 | K002274 | 000 |
| 03596010460011 | K002274 | 000 |
| 03596010460028 | K002274 | 000 |
| 03596010460110 | K002274 | 000 |
| 03596010460103 | K002274 | 000 |
| 03596010460097 | K002274 | 000 |
| 03596010460080 | K002274 | 000 |
| 03596010460073 | K002274 | 000 |
| 03596010460066 | K002274 | 000 |
| 03596010460059 | K002274 | 000 |
| 03596010460042 | K002274 | 000 |
| 03596010460035 | K002274 | 000 |
| 03596010459909 | K002274 | 000 |