ATEC IOM Accessory Instruments
by Alphatec Spine, Inc. 3 variants
510(k) K182617
ATEC IOM Accessory Instruments is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K182617 on 9 May 2019, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182617 | Date9 May 2019 | StatusActive |
Official records
- FDA 510(k) database K182617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PDQ
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1820
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PDQ (Neurosurgical Nerve Locator).
- SENTIO MMG Pedicle Access Needles by MEDOS INTERNATIONAL SARL
- 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 Curv XS by SpineGuard.S.A
- NuVasive NVM5 System by Nu Vasive, Incorporated
- NuVasive Next Generation NVM5 System by Nu Vasive, Incorporated
- iD3 Nav Decompression Probe (NTX-9005) by Neuralytix, LLC
- TELIGEN System Peripheral Motor Nerve Stimulation Indications by MEDOS INTERNATIONAL SARL
- Rhythmlink Disposable Concentric Stimulating Probe by Rhythmlink International, LLC
- PediGuard Threaded by SpineGuard.S.A
- Neuralytix iD3 System (NTX-9001) by Neuralytix, LLC
- ES2 Neuromonitoring Accessory Instruments by Stryker Corp.