510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PDQClass II

Neurosurgical Nerve Locator

21 CFR 874.1820 / Ear, Nose, Throat
FDA source (opens on fda.gov)

PDQ is the FDA product code for Neurosurgical Nerve Locator, a class II device type, regulated under 21 CFR 874.1820. FDA's definition for this code reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PDQ
Device name
Neurosurgical Nerve Locator
FDA definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
2

Clearances, product code PDQ

By decision year
36 clearances under product code PDQ with a decision year between 2013 and 2026, 2014 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code PDQ by decision year
YearClearances
20135
20147
20153
20163
20172
20184
20194
20212
20222
20231
20251
20262

Applicants with the most clearances

Product code PDQ
Applicants holding the most 510(k) clearances under product code PDQ
ApplicantClearances
Nu Vasive, Incorporated5
Spineguard, Inc.5
Alphatec Spine, Inc.3
Medos International SARL3
Boston Endo Surgical Tech2
Magstim Inc.2
Neuralytix LLC2
NuVasive Inc2
Tedan Surgical Innovations, Inc.2
Biomet Spine (Aka Ebi, LLC)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order