510(k) K140868
- Device
- STRYKER KWIC NEEDLE
- Applicant
- ORTHOVITA, INC.
- 510(k) number
- K140868
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-05
- Date received
- 2014-04-03
- 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
- John Urtz
- Address
- 77 Great Valley Pkwy. Malvern PA US 19355 19355
FDA Registration Numbers#
- 3010209365
- 2183456
- 3006405073
- 9610612
- 3018094310
- 3028006458
- 3006942548
- 3008868758
- 1057425
- 8043792
- 3015876273
- 3015877656
- 3017004815
- 3021008900
- 3014479313
- 3010123172
- 1835572
- 1226544
- 3008837339
- 3007366790
- 3010363476
- 3012322232
- 1824206
- 3020981894
- 2183319
- 3005180920
- 3005706667
- 2244478
- 3009185973
- 8039051
- 3010707607
- 3013302242
- 1061124
- 3033536255
- 3021632375
- 3002808157
- 3010009632
- 3023194190
- 3006846753
- 3004016520
- 3030412764
- 3009050824
- 3010370554
- 3012098629
- 3008114965
- 3003477135
- 1058084
- 3027616024
- 9613350
- 3033509898
- 2134470
- 3008812560
- 9612389
- 9611612
- 3003998208
- 3003761012
- 3004727093
- 3005677016
- 3010462278
- 3043543260
- 8030128
- 9611390
- 2031093
- 3022310762
- 3016050940
- 3009555447
- 3022232775
- 3016678045
- 3011050570
- 3036756245
- 3004188066
- 2434444
- 9612277
- 3008027912
- 9610617
- 1017294
- 3011015572
- 3011724582
- 1018470
- 3006697241
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262214 | Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) | Guangzhou Aimooe Technology Co., Ltd. | 2026-10-15 |
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026-09-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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