The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Bioraptor Curved 2.3 Pk Suture Anchors.
| Device ID | K102660 |
| 510k Number | K102660 |
| Device Name: | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Contact | Kathleen Solomon |
| Correspondent | Kathleen Solomon SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-12-13 |
| Summary: | summary |