The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Vitallium Hex-drive Bone Screw System.
| Device ID | K864633 |
| 510k Number | K864633 |
| Device Name: | VITALLIUM HEX-DRIVE BONE SCREW SYSTEM |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-25 |
| Decision Date | 1986-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036176 | K864633 | 000 |