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FDA 510(k)

101-32 FEMORAL COMPONENT

K-Number: K813599 · 1982-01-22

ApplicantIntermedics Orthopedics
Decision Date1982-01-22
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

101-32 FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813599. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 101-32 FEMORAL COMPONENT?

101-32 FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Intermedics Orthopedics. The 510(k) number is K813599.

When did 101-32 FEMORAL COMPONENT receive FDA 510(k) clearance?

101-32 FEMORAL COMPONENT received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813599.

Who is the listed applicant for 101-32 FEMORAL COMPONENT?

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

What is the FDA product code for 101-32 FEMORAL COMPONENT?

The FDA product code for 101-32 FEMORAL 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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