The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Speedscrew System.
| Device ID | K101448 |
| 510k Number | K101448 |
| Device Name: | OPUS SPEEDSCREW SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2010-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005233 | K101448 | 000 |
| 00817470005226 | K101448 | 000 |
| 00817470005219 | K101448 | 000 |
| 00817470005202 | K101448 | 000 |
| 00817470004625 | K101448 | 000 |
| 00817470004076 | K101448 | 000 |
| 00817470001259 | K101448 | 000 |