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FDA 510(k)

GDLH VARIABLE ANGLE CONNECTOR

K-Number: K934582 · 1994-06-21

ApplicantDanek Group, Inc.
Decision Date1994-06-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GDLH VARIABLE ANGLE CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Danek Group, Inc.. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K934582. 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 GDLH VARIABLE ANGLE CONNECTOR?

GDLH VARIABLE ANGLE CONNECTOR is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Danek Group, Inc.. The 510(k) number is K934582.

When did GDLH VARIABLE ANGLE CONNECTOR receive FDA 510(k) clearance?

GDLH VARIABLE ANGLE CONNECTOR received FDA 510(k) clearance on 1994-06-21, under 510(k) number K934582.

Who is the listed applicant for GDLH VARIABLE ANGLE CONNECTOR?

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

What is the FDA product code for GDLH VARIABLE ANGLE CONNECTOR?

The FDA product code for GDLH VARIABLE ANGLE CONNECTOR is KWP.

Related Clinical Trials

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.

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Other records listing Danek Group, 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.

K936307DYNA-LOK ANTERIOR PLATING SYSTEM

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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