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FDA 510(k)

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)

K-Number: K960087 · 1996-09-20

ApplicantWrightmedicaltechnologyinc
Decision Date1996-09-20
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K960087. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)?

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K960087.

When did SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) receive FDA 510(k) clearance?

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) received FDA 510(k) clearance on 1996-09-20, under 510(k) number K960087.

Who is the listed applicant for SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)?

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

What is the FDA product code for SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)?

The FDA product code for SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) is JDB.

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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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