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FDA 510(k)

ARMSTRONG SPINAL APPLIANCE

K-Number: K810224 · 1981-02-10

ApplicantHowmedica Corp.
Decision Date1981-02-10
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARMSTRONG SPINAL APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1981-02-10 under 510(k) number K810224. 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 ARMSTRONG SPINAL APPLIANCE?

ARMSTRONG SPINAL APPLIANCE is a medical device that received FDA 510(k) clearance on 1981-02-10. The listed applicant is Howmedica Corp.. The 510(k) number is K810224.

When did ARMSTRONG SPINAL APPLIANCE receive FDA 510(k) clearance?

ARMSTRONG SPINAL APPLIANCE received FDA 510(k) clearance on 1981-02-10, under 510(k) number K810224.

Who is the listed applicant for ARMSTRONG SPINAL APPLIANCE?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARMSTRONG SPINAL APPLIANCE?

The FDA product code for ARMSTRONG SPINAL APPLIANCE is KWP.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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