510(k) K993239
- Device
- STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
- Applicant
- STRYKER CORP.
- 510(k) number
- K993239
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-18
- Date received
- 1999-09-27
- 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
- NICOLE PETTY
- Address
- 4100 E. Milham Ave. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 1226188
- 3010009632
- 3002808157
- 3017565094
- 8010379
- 3009538961
- 8043933
- 1824206
- 3015797559
- 1828288
- 3010197224
- 3004464325
- 3011874573
- 3006783837
- 3035366890
- 3000270450
- 3009829742
- 1835572
- 3004024955
- 1018470
- 3004513872
- 1825034
- 3013557562
- 3010822102
- 3010032903
- 1836357
- 3007366790
- 1048735
- 3016678045
- 3010120104
- 3005718816
- 3011015572
- 3027305794
- 3010370554
- 3042048690
- 3021008900
- 3003418325
- 3006846753
- 3007539489
- 3003847101
- 3010363476
- 2424366
- 3005061536
- 3017603615
- 3003998208
- 3006405073
- 3010120148
- 3011724582
- 2011171
- 3003790304
- 3008027912
- 3021591288
- 3015112247
- 3012469182
- 3014967969
- 3009882675
- 3007014520
- 1720929
- 9610612
- 3009050824
- 3006128100
- 3036756245
- 3013485140
- 1043653
- 2245304
- 1450662
- 3009959868
- 3017210488
- 1424263
- 3012075008
- 3010202439
- 1219655
- 1928237
- 2031093
- 3005677016
- 3004016520
- 3030733800
- 3009888740
- 1061124
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 |
| 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 |
Legacy Summary#
summary
FDA Review#
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