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FDA 510(k)

STERISPINE LC CAGE

K-Number: K122021 · 2012-09-20

ApplicantSafe Orthopaedics
Decision Date2012-09-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERISPINE LC CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K122021. 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 STERISPINE LC CAGE?

STERISPINE LC CAGE is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Safe Orthopaedics. The 510(k) number is K122021.

When did STERISPINE LC CAGE receive FDA 510(k) clearance?

STERISPINE LC CAGE received FDA 510(k) clearance on 2012-09-20, under 510(k) number K122021.

Who is the listed applicant for STERISPINE LC CAGE?

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

What is the FDA product code for STERISPINE LC CAGE?

The FDA product code for STERISPINE LC CAGE is MAX.

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Other records listing Safe Orthopaedics 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.

K201648Sterispine™ PSK170528Sterispine™ PSK162531STERISPINE CCK130632STERISPINE PS PEDICLE SCREWK121299STERISPINEPS PEDICLE SCREW, STERISPINEPS RODK112453STERISPINEPS PEDICLE SCREW

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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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