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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840200404174 | K212088 | 000 |
| 00810045534930 | K212088 | 000 |
| 00810045534923 | K212088 | 000 |
| 00810045534916 | K212088 | 000 |
| 00810045534558 | K212088 | 000 |
| 00810045534541 | K212088 | 000 |
| 00810045534534 | K212088 | 000 |
| 00810045534527 | K212088 | 000 |
| 00810045534510 | K212088 | 000 |
| 00810045534503 | K212088 | 000 |
| 00810045534497 | K212088 | 000 |
| 00810045534480 | K212088 | 000 |
| 00810045534473 | K212088 | 000 |
| 00810045534947 | K212088 | 000 |
| 00810045534954 | K212088 | 000 |
| 00810045534961 | K212088 | 000 |
| 00840200404143 | K212088 | 000 |
| 00840200404099 | K212088 | 000 |
| 00840200404082 | K212088 | 000 |
| 00840200404075 | K212088 | 000 |
| 00810045535043 | K212088 | 000 |
| 00810045535036 | K212088 | 000 |
| 00810045535029 | K212088 | 000 |
| 00810045535012 | K212088 | 000 |
| 00810045535005 | K212088 | 000 |
| 00810045534992 | K212088 | 000 |
| 00810045534985 | K212088 | 000 |
| 00810045534978 | K212088 | 000 |
| 00810045534466 | K212088 | 000 |