The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Kasm Knee Articulating Spacer Molds.
| Device ID | K133449 |
| 510k Number | K133449 |
| Device Name: | KASM KNEE ARTICULATING SPACER MOLDS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Mike Ensign |
| Correspondent | Mike Ensign ORTHO DEVELOPMENT CORP. 12187 SOUTH 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 | 2013-11-12 |
| Decision Date | 2014-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409007608 | K133449 | 000 |
| 00822409043194 | K133449 | 000 |
| 00822409043200 | K133449 | 000 |
| 00822409043217 | K133449 | 000 |
| 00822409043224 | K133449 | 000 |
| 00822409043231 | K133449 | 000 |
| 00822409007554 | K133449 | 000 |
| 00822409007561 | K133449 | 000 |
| 00822409007578 | K133449 | 000 |
| 00822409007585 | K133449 | 000 |
| 00822409007592 | K133449 | 000 |
| 00822409043187 | K133449 | 000 |