The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Ortho Development Balanced Knee Tibial Tray Pegged.
| Device ID | K020383 |
| 510k Number | K020383 |
| Device Name: | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Carol Freasier |
| Correspondent | Carol Freasier ORTHO DEVELOPMENT CORP. 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409003211 | K020383 | 000 |
| 00822409003204 | K020383 | 000 |
| 00822409003198 | K020383 | 000 |
| 00822409003181 | K020383 | 000 |
| 00822409003174 | K020383 | 000 |
| 00822409003167 | K020383 | 000 |
| 00822409003150 | K020383 | 000 |