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FDA 510(k)

EDWARDS ADJUSTABLE CONNECTORS

K-Number: K915672 · 1993-05-26

ApplicantScientific Spinal , Ltd.
Decision Date1993-05-26
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EDWARDS ADJUSTABLE CONNECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Spinal , Ltd.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K915672. 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 EDWARDS ADJUSTABLE CONNECTORS?

EDWARDS ADJUSTABLE CONNECTORS is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Scientific Spinal , Ltd.. The 510(k) number is K915672.

When did EDWARDS ADJUSTABLE CONNECTORS receive FDA 510(k) clearance?

EDWARDS ADJUSTABLE CONNECTORS received FDA 510(k) clearance on 1993-05-26, under 510(k) number K915672.

Who is the listed applicant for EDWARDS ADJUSTABLE CONNECTORS?

The FDA 510(k) record lists Scientific Spinal , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS ADJUSTABLE CONNECTORS?

The FDA product code for EDWARDS ADJUSTABLE CONNECTORS 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 Scientific Spinal , Ltd. 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.

K914269EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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