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FDA 510(k)

REDONDO-L

K-Number: K103297 · 2011-01-27

ApplicantSeaspine, Inc.
Decision Date2011-01-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDONDO-L is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2011-01-27 under 510(k) number K103297. 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 REDONDO-L?

REDONDO-L is a medical device that received FDA 510(k) clearance on 2011-01-27. The listed applicant is Seaspine, Inc.. The 510(k) number is K103297.

When did REDONDO-L receive FDA 510(k) clearance?

REDONDO-L received FDA 510(k) clearance on 2011-01-27, under 510(k) number K103297.

Who is the listed applicant for REDONDO-L?

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

What is the FDA product code for REDONDO-L?

The FDA product code for REDONDO-L is MAX.

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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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