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FDA 510(k)

OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS

K-Number: K974434 · 1998-01-12

ApplicantOsteonics Corp.
Decision Date1998-01-12
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K974434. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS?

OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Osteonics Corp.. The 510(k) number is K974434.

When did OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS receive FDA 510(k) clearance?

OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS received FDA 510(k) clearance on 1998-01-12, under 510(k) number K974434.

Who is the listed applicant for OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS?

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 SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS?

The FDA product code for OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS is HRY.

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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: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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