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FDA 510(k)

DIAO HAND SURGERY SET

K-Number: K960539 · 1996-07-23

ApplicantKinetikos Medical, Inc.
Decision Date1996-07-23
Product CodeHXB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIAO HAND SURGERY SET is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 1996-07-23 under 510(k) number K960539. The device is classified under product code HXB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAO HAND SURGERY SET?

DIAO HAND SURGERY SET is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K960539.

When did DIAO HAND SURGERY SET receive FDA 510(k) clearance?

DIAO HAND SURGERY SET received FDA 510(k) clearance on 1996-07-23, under 510(k) number K960539.

Who is the listed applicant for DIAO HAND SURGERY SET?

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

What is the FDA product code for DIAO HAND SURGERY SET?

The FDA product code for DIAO HAND SURGERY SET is HXB.

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Other records listing Kinetikos Medical, 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.

K061749ECLIPSE TOTAL ANKLE IMPLANTK061465KMI CEMENT RESTRICTOR IMPLANTK051611MBARESORB IMPLANTK041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMK032806KATALYST RADIAL HEAD IMPLANTK040356KOMPRESSOR SCREW SYSTEM

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Related Devices (Code: HXB)

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.

K943472COHORT AVB RETRACTOR SYSTEMCohort Medical Products Group, Inc.K912843FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBEFlexmedicsK890227SURGICAL PROBEKinetic Medical ProductsK873652HOOK PROBE #TM-1376Arthropedics, Inc.K873651BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375Arthropedics, Inc.K863149BOWEN PROBEBowen & Company, Inc.

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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