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FDA 510(k)

MICRO-STRUC. ACETABULAR COMPON- MC2P

K-Number: K850352 · 1985-04-25

ApplicantOsteonics Corp.
Decision Date1985-04-25
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO-STRUC. ACETABULAR COMPON- MC2P is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K850352. 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 MICRO-STRUC. ACETABULAR COMPON- MC2P?

MICRO-STRUC. ACETABULAR COMPON- MC2P is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Osteonics Corp.. The 510(k) number is K850352.

When did MICRO-STRUC. ACETABULAR COMPON- MC2P receive FDA 510(k) clearance?

MICRO-STRUC. ACETABULAR COMPON- MC2P received FDA 510(k) clearance on 1985-04-25, under 510(k) number K850352.

Who is the listed applicant for MICRO-STRUC. ACETABULAR COMPON- MC2P?

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

What is the FDA product code for MICRO-STRUC. ACETABULAR COMPON- MC2P?

The FDA product code for MICRO-STRUC. ACETABULAR COMPON- MC2P is JDL.

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Other records listing Osteonics Corp. as applicant

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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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