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FDA 510(k)

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

K-Number: K850793 · 1985-05-09

ApplicantIntermedics Orthopedics
Decision Date1985-05-09
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1985-05-09 under 510(k) number K850793. 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 MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA?

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is Intermedics Orthopedics. The 510(k) number is K850793.

When did MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA receive FDA 510(k) clearance?

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA received FDA 510(k) clearance on 1985-05-09, under 510(k) number K850793.

Who is the listed applicant for MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA?

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 MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA?

The FDA product code for MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA 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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