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FDA 510(k)

OSTEONICS FX-CABLELOK GRIP COMPONENTS

K-Number: K980594 · 1998-05-05

ApplicantOsteonics Corp.
Decision Date1998-05-05
Product CodeLYT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS FX-CABLELOK GRIP COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-05-05 under 510(k) number K980594. The device is classified under product code LYT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS FX-CABLELOK GRIP COMPONENTS?

OSTEONICS FX-CABLELOK GRIP COMPONENTS is a medical device that received FDA 510(k) clearance on 1998-05-05. The listed applicant is Osteonics Corp.. The 510(k) number is K980594.

When did OSTEONICS FX-CABLELOK GRIP COMPONENTS receive FDA 510(k) clearance?

OSTEONICS FX-CABLELOK GRIP COMPONENTS received FDA 510(k) clearance on 1998-05-05, under 510(k) number K980594.

Who is the listed applicant for OSTEONICS FX-CABLELOK GRIP COMPONENTS?

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 FX-CABLELOK GRIP COMPONENTS?

The FDA product code for OSTEONICS FX-CABLELOK GRIP COMPONENTS is LYT.

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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: LYT)

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.

K040363CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.K983685BONE BANDChapel and Assoc.K914812K-CAP-E, STERILEWestcon Orthopedics, Inc.K912762K-CAP-I, STERILEWestcon Orthopedics, Inc.K902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, 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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