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FDA 510(k)

JULIET OL

K-Number: K101720 · 2010-07-16

ApplicantSpineart
Decision Date2010-07-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JULIET OL is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K101720. 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 JULIET OL?

JULIET OL is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Spineart. The 510(k) number is K101720.

When did JULIET OL receive FDA 510(k) clearance?

JULIET OL received FDA 510(k) clearance on 2010-07-16, under 510(k) number K101720.

Who is the listed applicant for JULIET OL?

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

What is the FDA product code for JULIET OL?

The FDA product code for JULIET OL is MAX.

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Other records listing Spineart 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.

K230774PERLA® TL System; TEKTONA® HV US Bone CementK213470PERLA® TL Posterior Osteosynthesis SystemK210472SPINEART Navigation Instrument SystemK203506PERLA® TL posterior osteosynthesis systemK203222PERLA TL Posterior Osteosynthesis SystemK200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

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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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