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FDA 510(k)

CANNULATED MALLEOLAR SCREW

K-Number: K931682 · 1994-04-05

ApplicantOnyx Medical Corp.
Decision Date1994-04-05
Product CodeKWK
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CANNULATED MALLEOLAR SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical Corp.. It received FDA 510(k) clearance on 1994-04-05 under 510(k) number K931682. The device is classified under product code KWK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CANNULATED MALLEOLAR SCREW?

CANNULATED MALLEOLAR SCREW is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Onyx Medical Corp.. The 510(k) number is K931682.

When did CANNULATED MALLEOLAR SCREW receive FDA 510(k) clearance?

CANNULATED MALLEOLAR SCREW received FDA 510(k) clearance on 1994-04-05, under 510(k) number K931682.

Who is the listed applicant for CANNULATED MALLEOLAR SCREW?

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

What is the FDA product code for CANNULATED MALLEOLAR SCREW?

The FDA product code for CANNULATED MALLEOLAR SCREW is KWK.

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Other records listing Onyx Medical Corp. 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.

K942022FACE-IT SHIELDK931690SPOON PLATEK934614MINI FRAGMENT PLATEK931692T-PLATEK931680CANNULATED CANCELLOUS SCREWK931684EPIPHYSIS PLATE

View all 47 devices →

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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