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FDA 510(k)

LOW PROFILE MID CROSS BRACING

K-Number: K931225 · 1994-05-02

ApplicantAdvanced Spine Fixation Systems, Inc.
Decision Date1994-05-02
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

LOW PROFILE MID CROSS BRACING is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Fixation Systems, Inc.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K931225. 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 LOW PROFILE MID CROSS BRACING?

LOW PROFILE MID CROSS BRACING is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Advanced Spine Fixation Systems, Inc.. The 510(k) number is K931225.

When did LOW PROFILE MID CROSS BRACING receive FDA 510(k) clearance?

LOW PROFILE MID CROSS BRACING received FDA 510(k) clearance on 1994-05-02, under 510(k) number K931225.

Who is the listed applicant for LOW PROFILE MID CROSS BRACING?

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

What is the FDA product code for LOW PROFILE MID CROSS BRACING?

The FDA product code for LOW PROFILE MID CROSS BRACING is KWP.

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Other records listing Advanced Spine Fixation Systems, 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.

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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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