510(k) K143159
- Device
- Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard
- Applicant
- SpineGuard, S.A.
- 510(k) number
- K143159
- Product code
- PDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-23
- Date received
- 2014-11-03
- Regulation
- 874.1820
- Classification name
- Neurosurgical Nerve Locator
- Medical specialty
- Ear Nose & Throat
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephane Bette
- Address
- 5-7 Rue De L’Amiral Courbet Saint Mande FR 94160 94160
FDA Registration Numbers#
- 3003935342
- 3005706667
- 3021948057
- 3004024955
- 1047843
- 3006128100
- 1221763
- 1211566
- 3005726885
- 1218017
- 3010123206
- 3008102049
- 1221485
- 3016438694
- 3030412764
- 1928237
- 3004464325
- 3007014520
- 1219114
- 3006639944
- 3042364673
- 3004598644
- 1319639
- 3008114965
- 3023852420
- 3007156625
- 1526439
- 3008868758
- 3007700286
- 1319660
- 3023164
- 3012263546
- 1220477
- 2246552
- 3043543260
- 2133772
- 2030624
- 3009959868
- 2027467
- 3004519921
- 3009973505
- 3019878714
- 2027062
- 3020018
- 3006418479
- 3006783837
- 3003080184
- 3007713076
- 3024673
- 3010047454
- 3009050824
- 3012495575
- 2031966
- 3010057495
- 3009144915
- 3012182497
- 8021774
- 1056553
Source Documents#
Other 510(k) Records For Product Code PDQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | 2026-04-26 |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025-06-26 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023-02-10 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022-09-23 |
| K220160 | PediGuard Threaded | Spineguard S.A. | 2022-03-31 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021-03-17 |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021-02-10 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-10-18 |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019-07-16 |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-05-09 |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | 2019-04-10 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018-11-09 |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | 2018-08-22 |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018-04-05 |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018-03-22 |
Legacy Summary#
summary
FDA Review#
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