The following data is part of a premarket notification filed by Integrity Implants Inc. with the FDA for Integrity Implants Navigated Instruments.
| Device ID | K212088 |
| 510k Number | K212088 |
| Device Name: | Integrity Implants Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Contact | Lauren Kamer |
| Correspondent | Roshana Ahmed TELOS Partners, LLC 571 Christina Lake Drive Lakeland, FL 33813 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2021-12-23 |