The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Alantech Graft Fixation Screw.
| Device ID | K031937 |
| 510k Number | K031937 |
| Device Name: | ALANTECH GRAFT FIXATION SCREW |
| 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 | 2003-06-23 |
| Decision Date | 2003-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006919 | K031937 | 000 |
| 00817470006902 | K031937 | 000 |
| 00817470006896 | K031937 | 000 |
| 00817470006889 | K031937 | 000 |
| 00817470006872 | K031937 | 000 |
| 00817470006865 | K031937 | 000 |
| 00817470006858 | K031937 | 000 |
| 00817470006841 | K031937 | 000 |
| 00817470006834 | K031937 | 000 |