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FDA 510(k)

SYNTHES ZERO-P

K-Number: K093762 · 2010-12-20

ApplicantSynthes Spine
Decision Date2010-12-20
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES ZERO-P is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K093762. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES ZERO-P?

SYNTHES ZERO-P is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Synthes Spine. The 510(k) number is K093762.

When did SYNTHES ZERO-P receive FDA 510(k) clearance?

SYNTHES ZERO-P received FDA 510(k) clearance on 2010-12-20, under 510(k) number K093762.

Who is the listed applicant for SYNTHES ZERO-P?

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 SYNTHES ZERO-P?

The FDA product code for SYNTHES ZERO-P is OVE.

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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: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

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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