The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for 6.2 Vitallium Alloy Cancellous Bone Screw.
| Device ID | K944213 |
| 510k Number | K944213 |
| Device Name: | 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1994-12-09 |