The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Vertefix Vertebroplasty Procedure Set.
| Device ID | K042691 |
| 510k Number | K042691 |
| Device Name: | VERTEFIX VERTEBROPLASTY PROCEDURE SET |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Jennifer J Bosley |
| Correspondent | Jennifer J Bosley COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2005-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212025570 | K042691 | 000 |
| 00815212024627 | K042691 | 000 |
| 00815212024429 | K042691 | 000 |
| 00815212026362 | K042691 | 000 |