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FDA 510(k)

MATRIX 3000 FLEXIBLE SPINE COIL

K-Number: K964753 · 1997-02-11

ApplicantUs Asia Instruments, Inc.
Decision Date1997-02-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MATRIX 3000 FLEXIBLE SPINE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Us Asia Instruments, Inc.. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K964753. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATRIX 3000 FLEXIBLE SPINE COIL?

MATRIX 3000 FLEXIBLE SPINE COIL is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Us Asia Instruments, Inc.. The 510(k) number is K964753.

When did MATRIX 3000 FLEXIBLE SPINE COIL receive FDA 510(k) clearance?

MATRIX 3000 FLEXIBLE SPINE COIL received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964753.

Who is the listed applicant for MATRIX 3000 FLEXIBLE SPINE COIL?

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

What is the FDA product code for MATRIX 3000 FLEXIBLE SPINE COIL?

The FDA product code for MATRIX 3000 FLEXIBLE SPINE COIL is LNH.

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Other records listing Us Asia Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K964820MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15AK964531PROFILE 70000 QUADRATURE VOLUME NECK COILK943440PROFILE 7000 C-SPINE COIL

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Official Source

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