The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Brainlab Compatible K2m Navigation Instruments.
| Device ID | K192911 |
| 510k Number | K192911 |
| Device Name: | Brainlab Compatible 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 | 2019-10-15 |
| Decision Date | 2019-11-14 |