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FDA 510(k)

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

K-Number: K914269 · 1991-12-18

ApplicantScientific Spinal , Ltd.
Decision Date1991-12-18
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO 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 1991-12-18 under 510(k) number K914269. 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 EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO?

EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Scientific Spinal , Ltd.. The 510(k) number is K914269.

When did EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO receive FDA 510(k) clearance?

EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914269.

Who is the listed applicant for EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO?

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

The FDA product code for EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO 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.

K915672EDWARDS ADJUSTABLE CONNECTORS

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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