The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Mss.
| Device ID | K961418 |
| 510k Number | K961418 |
| Device Name: | OSTEOMED MSS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Contact | James D Lafferty |
| Correspondent | James D Lafferty OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-10-25 |