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FDA 510(k)

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

K-Number: K895607 · 1989-11-17

ApplicantExactech, Inc.
Decision Date1989-11-17
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K895607. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT?

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Exactech, Inc.. The 510(k) number is K895607.

When did POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT receive FDA 510(k) clearance?

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT received FDA 510(k) clearance on 1989-11-17, under 510(k) number K895607.

Who is the listed applicant for POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT?

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

What is the FDA product code for POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT?

The FDA product code for POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT is JDL.

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Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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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