The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055n, 22-9065, 22-9065n.
| Device ID | K092133 |
| 510k Number | K092133 |
| Device Name: | ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2009-11-05 |
| Summary: | summary |