ATEC IOM Accessory Instruments
FDA 510(k) K182617 · Alphatec Spine, Inc.
510(k) numberK182617
Submission
- Device name
- ATEC IOM Accessory Instruments
- Applicant
- Alphatec Spine, Inc.
Carlsnad, CA, US - Received
- September 24, 2018
- Decision date
- May 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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Questions and answers
When was ATEC IOM Accessory Instruments cleared by the FDA?
ATEC IOM Accessory Instruments (K182617) received a 510(k) decision of Substantially Equivalent on May 9, 2019, 227 days after the submission was received.
What is the product code of K182617?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.