The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Labralock P Knotless Fixation Device.
| Device ID | K061349 |
| 510k Number | K061349 |
| Device Name: | OPUS LABRALOCK P KNOTLESS FIXATION DEVICE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 27130 A PASEO ESPADA SUITE 1427 San Juan Capistrano, CA 92675 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 27130 A PASEO ESPADA SUITE 1427 San Juan Capistrano, CA 92675 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-07-14 |
| Summary: | summary |