The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wright Plaster Of Paris Pellets.
| Device ID | K963562 |
| 510k Number | K963562 |
| Device Name: | WRIGHT PLASTER OF PARIS PELLETS |
| 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 | 1996-09-05 |
| Decision Date | 1997-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123824 | K963562 | 000 |
| 00840420123817 | K963562 | 000 |
| 00840420123800 | K963562 | 000 |
| 00840420123794 | K963562 | 000 |
| 00840420133649 | K963562 | 000 |
| 00840420133632 | K963562 | 000 |
| 00840420133472 | K963562 | 000 |
| 00840420133465 | K963562 | 000 |