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FDA 510(k)

HARRINGTON-TYPE INSTRU-SCOLIOSIS

K-Number: K840423 · 1984-03-23

ApplicantLink America, Inc.
Decision Date1984-03-23
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HARRINGTON-TYPE INSTRU-SCOLIOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840423. 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 HARRINGTON-TYPE INSTRU-SCOLIOSIS?

HARRINGTON-TYPE INSTRU-SCOLIOSIS is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Link America, Inc.. The 510(k) number is K840423.

When did HARRINGTON-TYPE INSTRU-SCOLIOSIS receive FDA 510(k) clearance?

HARRINGTON-TYPE INSTRU-SCOLIOSIS received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840423.

Who is the listed applicant for HARRINGTON-TYPE INSTRU-SCOLIOSIS?

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

What is the FDA product code for HARRINGTON-TYPE INSTRU-SCOLIOSIS?

The FDA product code for HARRINGTON-TYPE INSTRU-SCOLIOSIS is KWP.

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Other records listing Link America, Inc. as applicant

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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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