The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-dense Bone Void Filler.
| Device ID | K070437 |
| 510k Number | K070437 |
| Device Name: | PRO-DENSE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ryan M Belaney |
| Correspondent | Ryan M Belaney WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-05-09 |
| Summary: | summary |