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FDA 510(k)

COTREL-DUBOUSSET (CD) SPINAL

K-Number: K955807 · 1996-10-01

ApplicantSofamor Danek USA,Inc.
Decision Date1996-10-01
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

COTREL-DUBOUSSET (CD) SPINAL is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1996-10-01 under 510(k) number K955807. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COTREL-DUBOUSSET (CD) SPINAL?

COTREL-DUBOUSSET (CD) SPINAL is a medical device that received FDA 510(k) clearance on 1996-10-01. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K955807.

When did COTREL-DUBOUSSET (CD) SPINAL receive FDA 510(k) clearance?

COTREL-DUBOUSSET (CD) SPINAL received FDA 510(k) clearance on 1996-10-01, under 510(k) number K955807.

Who is the listed applicant for COTREL-DUBOUSSET (CD) SPINAL?

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

What is the FDA product code for COTREL-DUBOUSSET (CD) SPINAL?

The FDA product code for COTREL-DUBOUSSET (CD) SPINAL is KWP.

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Other records listing Sofamor Danek USA,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.

K991031COLORADO II SPINAL SYSTEMK984360COLORADO II SPINAL SYSTEMK992928CD HORIZON SPINAL SYSTEMK991036DANEK PLATE AND SCREW SYSTEMK991198DYNA-LOK PLUS SPINAL SYSTEMK991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATES

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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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