The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Continuum Porous Patellar.
| Device ID | K971789 |
| 510k Number | K971789 |
| Device Name: | IMPLEX CONTINUUM POROUS PATELLAR |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Contact | Glenn N Byrd |
| Correspondent | Glenn N Byrd IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-14 |
| Decision Date | 1997-07-24 |
| Summary: | summary |