The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Tag Rod Bioraptor Suture Anchor 7209317, 7209318.
| Device ID | K031685 |
| 510k Number | K031685 |
| Device Name: | TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Jason Bilobram |
| Correspondent | Jason Bilobram SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2003-07-01 |
| Summary: | summary |