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FDA 510(k)

HALIFAX SPINAL CLAMP

K-Number: K850039 · 1985-05-29

ApplicantLevtech, Inc.
Decision Date1985-05-29
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HALIFAX SPINAL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Levtech, Inc.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K850039. 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 SPINAL CLAMP?

HALIFAX SPINAL CLAMP is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Levtech, Inc.. The 510(k) number is K850039.

When did HALIFAX SPINAL CLAMP receive FDA 510(k) clearance?

HALIFAX SPINAL CLAMP received FDA 510(k) clearance on 1985-05-29, under 510(k) number K850039.

Who is the listed applicant for HALIFAX SPINAL CLAMP?

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

What is the FDA product code for HALIFAX SPINAL CLAMP?

The FDA product code for HALIFAX SPINAL CLAMP is KWP.

Related Clinical Trials

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.

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Other records listing Levtech, Inc. 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.

K910128LEVTECH TITANIUM BONE WIREK901144LEVTECH BONE SCREWK873693LEVTECH COMPOSITE TRACTION TONGSK874023LEVTECH CLAMP APPLIER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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