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FDA 510(k)

SPINEANALYER MODEL SAPOC

K-Number: K103475 · 2011-01-05

ApplicantOptasia Medical
Decision Date2011-01-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPINEANALYER MODEL SAPOC is the device name listed in this FDA 510(k) record. The listed applicant is Optasia Medical. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K103475. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINEANALYER MODEL SAPOC?

SPINEANALYER MODEL SAPOC is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Optasia Medical. The 510(k) number is K103475.

When did SPINEANALYER MODEL SAPOC receive FDA 510(k) clearance?

SPINEANALYER MODEL SAPOC received FDA 510(k) clearance on 2011-01-05, under 510(k) number K103475.

Who is the listed applicant for SPINEANALYER MODEL SAPOC?

The FDA 510(k) record lists Optasia Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINEANALYER MODEL SAPOC?

The FDA product code for SPINEANALYER MODEL SAPOC is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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