The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Orthosphere Ceramic Spherical Implant.
| Device ID | K030319 |
| 510k Number | K030319 |
| Device Name: | ORTHOSPHERE CERAMIC SPHERICAL IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Katie Logerot |
| Correspondent | Katie Logerot WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-30 |
| Decision Date | 2003-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420121813 | K030319 | 000 |
| 00840420121806 | K030319 | 000 |
| 00840420121790 | K030319 | 000 |
| 00840420121783 | K030319 | 000 |
| 00840420121776 | K030319 | 000 |
| 00840420121769 | K030319 | 000 |
| 00840420199263 | K030319 | 000 |
| 00840420199256 | K030319 | 000 |
| 00840420199232 | K030319 | 000 |