The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Exeter Intramedullary Bone Plug.
| Device ID | K980843 |
| 510k Number | K980843 |
| Device Name: | EXETER INTRAMEDULLARY BONE PLUG |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Frank Mass |
| Correspondent | Frank Mass HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-04 |
| Decision Date | 1998-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051087 | K980843 | 000 |
| 04546540167262 | K980843 | 000 |
| 04546540167255 | K980843 | 000 |
| 04546540167248 | K980843 | 000 |
| 04546540167231 | K980843 | 000 |
| 04546540167224 | K980843 | 000 |
| 04546540167200 | K980843 | 000 |
| 04546540167194 | K980843 | 000 |