The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Radial Head Replacement System.
| Device ID | K984290 |
| 510k Number | K984290 |
| Device Name: | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John Schalago |
| Correspondent | John Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-01 |
| Decision Date | 1999-06-01 |
| Summary: | summary |