510(k) K242575
- Device
- Stereotaxic Guiding Surgical Devices, NaoTrac S
- Applicant
- Brain Navi Biotechnology Co., Ltd.
- 510(k) number
- K242575
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-23
- Date received
- 2024-08-29
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- I-Ju Lu
- Address
- # 66-1, Shengyi 5th Rd., Zhubei City Hsinchu County TW 302041 302041
FDA Registration Numbers
- 3005075696
- 3006128100
- 8010379
- 1056553
- 3028006458
- 3007515069
- 2528981
- 9610612
- 1222313
- 3010197224
- 2244478
- 3013726944
- 3021008900
- 3002250546
- 3003847101
- 2133772
- 8039051
- 2183456
- 1226188
- 8010177
- 8043933
- 3027305794
- 3033536255
- 3018708317
- 3010363476
- 3008627763
- 3011874573
- 3033509898
- 3011050570
- 3008110533
- 3010047454
- 3005874553
- 3010202439
- 8030128
- 3002907620
- 2032112
- 3018094310
- 1047843
- 2011171
- 3009973505
- 3010863450
- 1043653
- 1048735
- 3023194190
- 3002808157
- 1319639
- 2182979
- 3009185973
- 3004608878
- 3012352782
- 3008868758
- 2245304
- 1928237
- 2183671
- 2434444
- 1058084
- 3002807090
- 3022232775
- 3027375826
- 1018470
- 3005216725
- 2031966
- 3017636737
- 3007014520
- 3009144915
- 3002743211
- 8043792
- 3010120148
- 1057425
- 3009538961
- 1526439
- 1836357
- 3014479313
- 3004024955
- 1818910
- 3017603615
- 3005061536
- 3009888740
- 3003761012
Source Documents
Other 510(k) Records For Product Code HAW
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| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 |