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FDA 510(k)

SELBY II INSTRUMENTATION

K-Number: K895296 · 1990-03-20

ApplicantAdvanced Spine Fixation
Decision Date1990-03-20
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SELBY II INSTRUMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Fixation. It received FDA 510(k) clearance on 1990-03-20 under 510(k) number K895296. 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 SELBY II INSTRUMENTATION?

SELBY II INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1990-03-20. The listed applicant is Advanced Spine Fixation. The 510(k) number is K895296.

When did SELBY II INSTRUMENTATION receive FDA 510(k) clearance?

SELBY II INSTRUMENTATION received FDA 510(k) clearance on 1990-03-20, under 510(k) number K895296.

Who is the listed applicant for SELBY II INSTRUMENTATION?

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

What is the FDA product code for SELBY II INSTRUMENTATION?

The FDA product code for SELBY II INSTRUMENTATION is KWP.

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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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