The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Super Screw 3.5 Mm.
| Device ID | K954330 |
| 510k Number | K954330 |
| Device Name: | SUPER SCREW 3.5 MM |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Contact | Steve Pubols |
| Correspondent | Steve Pubols OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-12-08 |