The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Exeter Intramedullary Bone Plug.
| Device ID | K933077 |
| 510k Number | K933077 |
| Device Name: | EXETER INTRAMEDULLARY BONE PLUG |
| Classification | Cement Obturator |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1995-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540167460 | K933077 | 000 |
| 04546540167453 | K933077 | 000 |
| 04546540167446 | K933077 | 000 |
| 04546540167439 | K933077 | 000 |
| 04546540167422 | K933077 | 000 |
| 04546540167415 | K933077 | 000 |