510(k) K162929
- Device
- Stryker Navigation System With CranialMap Software Application, Stryker CranialMap Planning Software Application, Stryker CranialMask Tracker
- Applicant
- Stryker Corporation
- 510(k) number
- K162929
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-22
- Date received
- 2016-10-19
- 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
- No
Applicant Contact#
- Contact
- Brittney M. Larsen
- Address
- Botzinger Strasse 41 Freiburg Baden-Wurttemberg DE D-79111 D-79111
FDA Registration Numbers#
- 1226188
- 2031966
- 1424263
- 3012322232
- 3042048690
- 3015536273
- 3003761012
- 3016678045
- 3035366890
- 1625507
- 1723170
- 3018708317
- 3005075696
- 3012447612
- 3004608878
- 1824206
- 2182979
- 9617840
- 3014596751
- 1825034
- 3020981894
- 3015207155
- 3007014520
- 3043543260
- 3010120104
- 3005180920
- 3010041430
- 1056553
- 2011171
- 2183319
- 1057425
- 3003955307
- 3030733800
- 3010362364
- 3015797559
- 3008627763
- 3038503932
- 9611894
- 3009144915
- 3005216725
- 1017294
- 1722447
- 3011050570
- 8030128
- 3017004815
- 3027305794
- 2183456
- 1043653
- 3004188066
- 3007147067
- 1833920
- 3010209365
- 3017210488
- 3010363476
- 3010822102
- 3010197224
- 8010871
- 3003525643
- 3013176080
- 3008868758
- 9612389
- 3015542154
- 3021632375
- 9611390
- 3014170143
- 1835572
- 3025603301
- 3022232775
- 1319639
- 3023194190
- 3013726944
- 1123169
- 1018470
- 1526534
- 3008837339
- 3006405073
- 3004024955
- 3010047454
- 3009555447
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | 2025-01-28 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 |
| 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 |
Legacy Summary#
summary
FDA Review#
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