The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedice Bone Plug.
| Device ID | K951860 |
| 510k Number | K951860 |
| Device Name: | HOWMEDICE BONE PLUG |
| Classification | Cement Obturator |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer 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 | 1995-04-21 |
| Decision Date | 1995-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036695 | K951860 | 000 |
| 07613327036671 | K951860 | 000 |
| 07613327036664 | K951860 | 000 |