The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Tram.
| Device ID | K963394 |
| 510k Number | K963394 |
| Device Name: | OSTEOMED TRAM |
| Classification | Plate, Bone |
| 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-28 |
| Decision Date | 1996-11-14 |