The following data is part of a premarket notification filed by O'tec Corp. with the FDA for Cortical Bone Screw (european Style).
| Device ID | K905357 |
| 510k Number | K905357 |
| Device Name: | CORTICAL BONE SCREW (EUROPEAN STYLE) |
| Classification | Screw, Fixation, Bone |
| Applicant | O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| Contact | Ricardo Heros |
| Correspondent | Ricardo Heros O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| 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 | 1990-11-28 |
| Decision Date | 1991-01-04 |