FDA 510(k)

ROPER-TUKE ELBOW

K-Number: K873660 · 1988-01-06

Decision Date1988-01-06

Product CodeJDB

Advisory CommitteeOR

DecisionSubstantially Equivalent for Some Indications

Device Summary

ROPER-TUKE ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1988-01-06 under 510(k) number K873660. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ROPER-TUKE ELBOW?

ROPER-TUKE ELBOW is a medical device that received FDA 510(k) clearance on 1988-01-06. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K873660.

When did ROPER-TUKE ELBOW receive FDA 510(k) clearance?

ROPER-TUKE ELBOW received FDA 510(k) clearance on 1988-01-06, under 510(k) number K873660.

Who is the listed applicant for ROPER-TUKE ELBOW?

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

What is the FDA product code for ROPER-TUKE ELBOW?

The FDA product code for ROPER-TUKE ELBOW is JDB.

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Other records listing Orthopedic Systems, Inc. as applicant

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Related Devices (Code: 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.