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FDA 510(k)

CD SPINAL SYSTEM

K-Number: K964159 · 1997-10-16

ApplicantSofamor Danek USA,Inc.
Decision Date1997-10-16
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CD SPINAL SYSTEM 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 1997-10-16 under 510(k) number K964159. 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 CD SPINAL SYSTEM?

CD SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K964159.

When did CD SPINAL SYSTEM receive FDA 510(k) clearance?

CD SPINAL SYSTEM received FDA 510(k) clearance on 1997-10-16, under 510(k) number K964159.

Who is the listed applicant for CD SPINAL SYSTEM?

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 CD SPINAL SYSTEM?

The FDA product code for CD SPINAL SYSTEM 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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