The following data is part of a premarket notification filed by Intra-lock International, Inc. with the FDA for Intra-lock Bone Fixation System.
| Device ID | K171831 |
| 510k Number | K171831 |
| Device Name: | Intra-Lock Bone Fixation System |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | Intra-Lock International, Inc. 6560 West Rogers Circle Bldg 24 Boca Raton, FL 33487 |
| Contact | Mary L. Jean |
| Correspondent | Mary L. Jean Intra-Lock International, Inc. 6560 West Rogers Circle Bldg 24 Boca Raton, FL 33487 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-10-26 |
| Summary: | summary |