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FDA 510(k)

RESTORE TUNNEL PLUG

K-Number: K923069 · 1993-06-08

ApplicantDepuy, Inc.
Decision Date1993-06-08
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESTORE TUNNEL PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1993-06-08 under 510(k) number K923069. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORE TUNNEL PLUG?

RESTORE TUNNEL PLUG is a medical device that received FDA 510(k) clearance on 1993-06-08. The listed applicant is Depuy, Inc.. The 510(k) number is K923069.

When did RESTORE TUNNEL PLUG receive FDA 510(k) clearance?

RESTORE TUNNEL PLUG received FDA 510(k) clearance on 1993-06-08, under 510(k) number K923069.

Who is the listed applicant for RESTORE TUNNEL PLUG?

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

What is the FDA product code for RESTORE TUNNEL PLUG?

The FDA product code for RESTORE TUNNEL PLUG is HRX.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: HRX)

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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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