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FDA 510(k)

INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES

K-Number: K082260 · 2008-10-17

ApplicantCalvary Spine, LLC
Decision Date2008-10-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES is the device name listed in this FDA 510(k) record. The listed applicant is Calvary Spine, LLC. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K082260. 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 INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES?

INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Calvary Spine, LLC. The 510(k) number is K082260.

When did INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES receive FDA 510(k) clearance?

INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES received FDA 510(k) clearance on 2008-10-17, under 510(k) number K082260.

Who is the listed applicant for INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES?

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

What is the FDA product code for INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES?

The FDA product code for INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES 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 Calvary Spine, 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.

K201568Calvary Spine Pedicle Screw System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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