SENTIO MMG Pedicle Access Needles
FDA 510(k) K173134 · Medos International SARL
510(k) numberK173134
Submission
- Device name
- SENTIO MMG Pedicle Access Needles
- Applicant
- Medos International SARL
Lelocle, CH - Received
- September 29, 2017
- Decision date
- March 22, 2018
- 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 SENTIO MMG Pedicle Access Needles cleared by the FDA?
SENTIO MMG Pedicle Access Needles (K173134) received a 510(k) decision of Substantially Equivalent on March 22, 2018, 174 days after the submission was received.
What is the product code of K173134?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.