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FDA 510(k)

PROW FUSION

K-Number: K130254 · 2013-10-16

ApplicantNlt Spine, Ltd.
Decision Date2013-10-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROW FUSION is the device name listed in this FDA 510(k) record. The listed applicant is Nlt Spine, Ltd.. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K130254. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROW FUSION?

PROW FUSION is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Nlt Spine, Ltd.. The 510(k) number is K130254.

When did PROW FUSION receive FDA 510(k) clearance?

PROW FUSION received FDA 510(k) clearance on 2013-10-16, under 510(k) number K130254.

Who is the listed applicant for PROW FUSION?

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

What is the FDA product code for PROW FUSION?

The FDA product code for PROW FUSION is MAX.

Related Clinical Trials

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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Other records listing Nlt Spine, Ltd. 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.

K153665PROW FUSION-LK153786PROW FUSION-VK133061ESPIN SYSTEMK130057ESPINK120553ESPINK112359PROW FUSION

View all 7 devices →

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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