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FDA 510(k)

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM

K-Number: K963045 · 1997-02-13

ApplicantSynthes (Usa)
Decision Date1997-02-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K963045. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM?

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Synthes (Usa). The 510(k) number is K963045.

When did SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM receive FDA 510(k) clearance?

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM received FDA 510(k) clearance on 1997-02-13, under 510(k) number K963045.

Who is the listed applicant for SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM?

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

What is the FDA product code for SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM?

The FDA product code for SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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