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FDA 510(k)

TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)

K-Number: K901005 · 1990-12-10

ApplicantDanek Medical, Inc.
Decision Date1990-12-10
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1990-12-10 under 510(k) number K901005. 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 TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)?

TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) is a medical device that received FDA 510(k) clearance on 1990-12-10. The listed applicant is Danek Medical, Inc.. The 510(k) number is K901005.

When did TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) receive FDA 510(k) clearance?

TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) received FDA 510(k) clearance on 1990-12-10, under 510(k) number K901005.

Who is the listed applicant for TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)?

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

What is the FDA product code for TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)?

The FDA product code for TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) is KWP.

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Other records listing Danek Medical, 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.

K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118K993810CD HORIZON SPINAL SYSTEMK993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMK991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORK990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMK982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

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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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