The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Hoffmann Fixation Pin System.
| Device ID | K861766 |
| 510k Number | K861766 |
| Device Name: | HOWMEDICA HOFFMANN FIXATION PIN SYSTEM |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-07 |
| Decision Date | 1986-07-08 |