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FDA 510(k)

APEX SPINE SYSTEM W/ COCR RODS

K-Number: K102488 · 2010-12-10

ApplicantSpinecraft, LLC
Decision Date2010-12-10
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX SPINE SYSTEM W/ COCR RODS is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2010-12-10 under 510(k) number K102488. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX SPINE SYSTEM W/ COCR RODS?

APEX SPINE SYSTEM W/ COCR RODS is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Spinecraft, LLC. The 510(k) number is K102488.

When did APEX SPINE SYSTEM W/ COCR RODS receive FDA 510(k) clearance?

APEX SPINE SYSTEM W/ COCR RODS received FDA 510(k) clearance on 2010-12-10, under 510(k) number K102488.

Who is the listed applicant for APEX SPINE SYSTEM W/ COCR RODS?

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

What is the FDA product code for APEX SPINE SYSTEM W/ COCR RODS?

The FDA product code for APEX SPINE SYSTEM W/ COCR RODS is MNH. This falls under the ENT category.

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Other records listing Spinecraft, LLC 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.

K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemK223273ASTRA Spine SystemK211935ORIO-Ti Intervertebral Body Fusion Cage SystemK211323ASTRA Spine SystemK181350ASTRA-OCT Spine SystemK131521VELOX ANTERIOR CERVICAL PLATE SYSTEM

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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