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FDA 510(k)

ROUND STAPLE

K-Number: K903271 · 1990-07-30

ApplicantOnyx Medical Corp.
Decision Date1990-07-30
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROUND STAPLE 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 1990-07-30 under 510(k) number K903271. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROUND STAPLE?

ROUND STAPLE is a medical device that received FDA 510(k) clearance on 1990-07-30. The listed applicant is Onyx Medical Corp.. The 510(k) number is K903271.

When did ROUND STAPLE receive FDA 510(k) clearance?

ROUND STAPLE received FDA 510(k) clearance on 1990-07-30, under 510(k) number K903271.

Who is the listed applicant for ROUND STAPLE?

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 ROUND STAPLE?

The FDA product code for ROUND STAPLE is JDR.

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Other records listing Onyx Medical Corp. as applicant

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

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Related Devices (Code: JDR)

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.

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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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