The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Titanium Hoffmann Fixation Pin System.
| Device ID | K982068 |
| 510k Number | K982068 |
| Device Name: | HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Sean Luland |
| Correspondent | Sean Luland HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-12 |
| Decision Date | 1998-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327091991 | K982068 | 000 |
| 07613327091922 | K982068 | 000 |
| 07613327091892 | K982068 | 000 |
| 07613327091885 | K982068 | 000 |