The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wright Plaster Of Paris Bone Void Filler Kit (subject To Revision).
| Device ID | K963587 |
| 510k Number | K963587 |
| Device Name: | WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Robert Churinetz |
| Correspondent | Robert Churinetz 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 | 1996-09-09 |
| Decision Date | 1997-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133687 | K963587 | 000 |
| 00840420133670 | K963587 | 000 |
| 00840420133489 | K963587 | 000 |
| 00840420133434 | K963587 | 000 |