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FDA 510(k)

ORACLE SPACER, OPAL SPACER

K-Number: K072791 · 2007-12-26

ApplicantSynthes Spine
Decision Date2007-12-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORACLE SPACER, OPAL SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2007-12-26 under 510(k) number K072791. 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 ORACLE SPACER, OPAL SPACER?

ORACLE SPACER, OPAL SPACER is a medical device that received FDA 510(k) clearance on 2007-12-26. The listed applicant is Synthes Spine. The 510(k) number is K072791.

When did ORACLE SPACER, OPAL SPACER receive FDA 510(k) clearance?

ORACLE SPACER, OPAL SPACER received FDA 510(k) clearance on 2007-12-26, under 510(k) number K072791.

Who is the listed applicant for ORACLE SPACER, OPAL SPACER?

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

What is the FDA product code for ORACLE SPACER, OPAL SPACER?

The FDA product code for ORACLE SPACER, OPAL SPACER is MAX.

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Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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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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