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FDA 510(k)

OSTEONICS RESTORATION ACETABULAR RING

K-Number: K970957 · 1997-06-03

ApplicantOsteonics Corp.
Decision Date1997-06-03
Product CodeJDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEONICS RESTORATION ACETABULAR RING is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K970957. The device is classified under product code JDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS RESTORATION ACETABULAR RING?

OSTEONICS RESTORATION ACETABULAR RING is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Osteonics Corp.. The 510(k) number is K970957.

When did OSTEONICS RESTORATION ACETABULAR RING receive FDA 510(k) clearance?

OSTEONICS RESTORATION ACETABULAR RING received FDA 510(k) clearance on 1997-06-03, under 510(k) number K970957.

Who is the listed applicant for OSTEONICS RESTORATION ACETABULAR RING?

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 OSTEONICS RESTORATION ACETABULAR RING?

The FDA product code for OSTEONICS RESTORATION ACETABULAR RING is JDJ.

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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: JDJ)

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.

K972760LINK, ACETABULAR REVISION MESH CUPLink America, Inc.K963940EXETER MESHHowmedica, Inc.K962541REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.K962007PROTRUSION CAGESDepuy, Inc.K925883OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.K890450INTERMEDICS APR(TM) II FEMORAL COMPONENTIntermedics Orthopedics

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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