The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-dense Bone Graft Substitute.
| Device ID | K113871 |
| 510k Number | K113871 |
| Device Name: | PRO-DENSE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Samir Ibrahim |
| Correspondent | Samir Ibrahim WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2013-03-25 |
| Summary: | summary |