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FDA 510(k)

SPINEOLOGY SPINOUS PROCESS PLATE

K-Number: K123232 · 2013-02-07

ApplicantSpineology, Inc.
Decision Date2013-02-07
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINEOLOGY SPINOUS PROCESS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K123232. 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 SPINEOLOGY SPINOUS PROCESS PLATE?

SPINEOLOGY SPINOUS PROCESS PLATE is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Spineology, Inc.. The 510(k) number is K123232.

When did SPINEOLOGY SPINOUS PROCESS PLATE receive FDA 510(k) clearance?

SPINEOLOGY SPINOUS PROCESS PLATE received FDA 510(k) clearance on 2013-02-07, under 510(k) number K123232.

Who is the listed applicant for SPINEOLOGY SPINOUS PROCESS PLATE?

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

What is the FDA product code for SPINEOLOGY SPINOUS PROCESS PLATE?

The FDA product code for SPINEOLOGY SPINOUS PROCESS PLATE is KWP.

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Other records listing Spineology, 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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