510(k) K031770
- Device
- CI TKR/UKR
- Applicant
- BRAINLAB, AG
- 510(k) number
- K031770
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-12
- Date received
- 2003-06-09
- 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
- RAINER BIRKENBACH
- Address
- Ammerthalstrasse 8 Heimstetten DE 85551 85551
FDA Registration Numbers#
- 3010123206
- 3014596751
- 3030733800
- 3005216725
- 8043933
- 3003525643
- 3021008900
- 3016438694
- 3012447612
- 3004753785
- 3015876273
- 2183319
- 3008027912
- 3021591288
- 1450662
- 3007515069
- 2031917
- 2030624
- 3027375826
- 3008114965
- 1226188
- 3010363476
- 3012098629
- 3014967969
- 3012322232
- 3006405073
- 3005796366
- 3016577622
- 3008868758
- 3012352782
- 3015877656
- 3004608878
- 3010863450
- 1625507
- 3017565094
- 3021632375
- 3017636737
- 1225492
- 3010120104
- 3008812560
- 1045254
- 3011724582
- 1833920
- 3015131155
- 3011015572
- 3013557562
- 3008738628
- 3010707607
- 1222313
- 3002808022
- 1526439
- 3002807090
- 3013176080
- 8010379
- 3003955307
- 9610617
- 1057425
- 8010871
- 3009882675
- 1836357
- 8040537
- 3007014520
- 3004105270
- 2133772
- 3038503932
- 8043792
- 1824206
- 3005061536
- 3009959868
- 1834331
- 1058084
- 3013485140
- 3017210488
- 3005677016
- 9613350
- 2183456
- 2183671
- 3010120135
- 3009973505
- 3002250546
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 |
Legacy Summary#
summary
FDA Review#
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