The following data is part of a premarket notification filed by Rog Sports Medicine, Inc. with the FDA for Rog Suture Anchor.
| Device ID | K113299 |
| 510k Number | K113299 |
| Device Name: | ROG SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ROG SPORTS MEDICINE, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond ROG SPORTS MEDICINE, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2011-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855152006038 | K113299 | 000 |
| 10855152006021 | K113299 | 000 |
| 10855152006014 | K113299 | 000 |
| 00855152006000 | K113299 | 000 |
| 00855152006048 | K113299 | 000 |