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FDA 510(k)

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON

K-Number: K933205 · 1994-05-04

ApplicantDanek Medical, Inc.
Decision Date1994-05-04
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON 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 1994-05-04 under 510(k) number K933205. 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(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON?

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Danek Medical, Inc.. The 510(k) number is K933205.

When did TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON receive FDA 510(k) clearance?

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON received FDA 510(k) clearance on 1994-05-04, under 510(k) number K933205.

Who is the listed applicant for TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON?

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(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON?

The FDA product code for TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON is KWP.

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Other records listing Danek Medical, Inc. as applicant

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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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