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FDA 510(k)

TENOR SPINAL SYSTEM

K-Number: K982490 · 1998-10-05

ApplicantSofamor Danek USA,Inc.
Decision Date1998-10-05
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENOR 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 1998-10-05 under 510(k) number K982490. 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 TENOR SPINAL SYSTEM?

TENOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-05. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K982490.

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

TENOR SPINAL SYSTEM received FDA 510(k) clearance on 1998-10-05, under 510(k) number K982490.

Who is the listed applicant for TENOR 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 TENOR SPINAL SYSTEM?

The FDA product code for TENOR 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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