The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Spinewand Surgical Device.
| Device ID | K100353 |
| 510k Number | K100353 |
| Device Name: | SPINEWAND SURGICAL DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470007503 | K100353 | 000 |
| 00817470007497 | K100353 | 000 |
| 00817470007480 | K100353 | 000 |