The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Navigation Instruments.
| Device ID | K201006 |
| 510k Number | K201006 |
| Device Name: | K2M Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Oonagh Lahiff |
| Correspondent | Megan Callanan Stryker 2 Pearl Court Allendale, NJ 07401 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857486980 | K201006 | 000 |
| 10888857523814 | K201006 | 000 |
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| 10888857415973 | K201006 | 000 |
| 10888857523951 | K201006 | 000 |
| 10888857523869 | K201006 | 000 |
| 10888857523852 | K201006 | 000 |
| 10888857549432 | K201006 | 000 |