The following data is part of a premarket notification filed by K2m with the FDA for K2m Navigation Instruments.
| Device ID | K171556 |
| 510k Number | K171556 |
| Device Name: | K2M Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | K2M 600 Hope Parkway SE Leesburge, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2018-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857411586 | K171556 | 000 |
| 10888857404991 | K171556 | 000 |
| 10888857249615 | K171556 | 000 |
| 10888857421387 | K171556 | 000 |
| 10888857421370 | K171556 | 000 |
| 10888857421363 | K171556 | 000 |
| 10888857411616 | K171556 | 000 |
| 10888857411609 | K171556 | 000 |
| 10888857411593 | K171556 | 000 |
| 10888857411500 | K171556 | 000 |
| 10888857405493 | K171556 | 000 |
| 10888857405486 | K171556 | 000 |
| 10888857405134 | K171556 | 000 |
| 10888857405127 | K171556 | 000 |
| 10888857405110 | K171556 | 000 |
| 10888857405103 | K171556 | 000 |
| 10888857405097 | K171556 | 000 |
| 10888857405004 | K171556 | 000 |
| 10888857405035 | K171556 | 000 |
| 10888857411579 | K171556 | 000 |
| 10888857411562 | K171556 | 000 |
| 10888857411548 | K171556 | 000 |
| 10888857411524 | K171556 | 000 |
| 10888857405523 | K171556 | 000 |
| 10888857405196 | K171556 | 000 |
| 10888857405189 | K171556 | 000 |
| 10888857405172 | K171556 | 000 |
| 10888857405165 | K171556 | 000 |
| 10888857405158 | K171556 | 000 |
| 10888857405141 | K171556 | 000 |
| 10888857405080 | K171556 | 000 |
| 10888857405073 | K171556 | 000 |
| 10888857405066 | K171556 | 000 |
| 10888857405059 | K171556 | 000 |
| 10888857405042 | K171556 | 000 |
| 10888857405011 | K171556 | 000 |