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FDA 510(k)

DEPUY AE TK2 HIP SCREW SYSTEM

K-Number: K972629 · 1997-10-09

ApplicantDepuy, Inc.
Decision Date1997-10-09
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY AE TK2 HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K972629. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY AE TK2 HIP SCREW SYSTEM?

DEPUY AE TK2 HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Depuy, Inc.. The 510(k) number is K972629.

When did DEPUY AE TK2 HIP SCREW SYSTEM receive FDA 510(k) clearance?

DEPUY AE TK2 HIP SCREW SYSTEM received FDA 510(k) clearance on 1997-10-09, under 510(k) number K972629.

Who is the listed applicant for DEPUY AE TK2 HIP SCREW SYSTEM?

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 DEPUY AE TK2 HIP SCREW SYSTEM?

The FDA product code for DEPUY AE TK2 HIP SCREW SYSTEM is KTT.

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Related Devices (Code: KTT)

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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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