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FDA 510(k)

AME(R) RIGID FIXATION SYSTEM

K-Number: K930531 · 1994-02-01

ApplicantAmerican Medical Electronics, Inc.
Decision Date1994-02-01
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AME(R) RIGID FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Electronics, Inc.. It received FDA 510(k) clearance on 1994-02-01 under 510(k) number K930531. 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 AME(R) RIGID FIXATION SYSTEM?

AME(R) RIGID FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-01. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K930531.

When did AME(R) RIGID FIXATION SYSTEM receive FDA 510(k) clearance?

AME(R) RIGID FIXATION SYSTEM received FDA 510(k) clearance on 1994-02-01, under 510(k) number K930531.

Who is the listed applicant for AME(R) RIGID FIXATION SYSTEM?

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

What is the FDA product code for AME(R) RIGID FIXATION SYSTEM?

The FDA product code for AME(R) RIGID FIXATION SYSTEM is KWP.

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Other records listing American Medical Electronics, 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.

K951232EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MMK952348OGDEN ANCHORK950875OGDEN ANCHORK951493OGDEN ANCHORK951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONSK941029OGDEN ANCHOR-SMALL (TENTATIVE)

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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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