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FDA 510(k)

HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM

K-Number: K962314 · 1996-12-09

ApplicantOsteonics Corp.
Decision Date1996-12-09
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K962314. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM?

HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Osteonics Corp.. The 510(k) number is K962314.

When did HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM receive FDA 510(k) clearance?

HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM received FDA 510(k) clearance on 1996-12-09, under 510(k) number K962314.

Who is the listed applicant for HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM?

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 HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM?

The FDA product code for HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM is KWP.

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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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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