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FDA 510(k)

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)

K-Number: K964933 · 1997-02-03

ApplicantMekanika, Inc.
Decision Date1997-02-03
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) is the device name listed in this FDA 510(k) record. The listed applicant is Mekanika, Inc.. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K964933. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)?

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Mekanika, Inc.. The 510(k) number is K964933.

When did MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) receive FDA 510(k) clearance?

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964933.

Who is the listed applicant for MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)?

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

What is the FDA product code for MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)?

The FDA product code for MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) is LBB.

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Official Source

View on FDA Database →

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

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