The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Mainstay Anchor.
| Device ID | K965175 |
| 510k Number | K965175 |
| Device Name: | HOWMEDICA MAINSTAY ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540792549 | K965175 | 000 |
| 04546540792525 | K965175 | 000 |
| 04546540792518 | K965175 | 000 |
| 04546540792501 | K965175 | 000 |
| 04546540792495 | K965175 | 000 |