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FDA 510(k)

BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM

K-Number: K894184 · 1990-04-25

ApplicantBiedermann Motech GmbH
Decision Date1990-04-25
Product CodeJDN
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Motech GmbH. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K894184. The device is classified under product code JDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM?

BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Biedermann Motech GmbH. The 510(k) number is K894184.

When did BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM receive FDA 510(k) clearance?

BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM received FDA 510(k) clearance on 1990-04-25, under 510(k) number K894184.

Who is the listed applicant for BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM?

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

What is the FDA product code for BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM?

The FDA product code for BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM is JDN.

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 Biedermann Motech GmbH 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.

K900138MOTECH TITANIUM SURGICAL MESH

Related Devices (Code: JDN)

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.

K954856CANNULATED FEMORAL NAILSynthes (Usa)K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOStuartK873977NEW C-D SYSTEM FOR SPINAL SURGERYSofamor Co.K872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYRoseburg SAK760649TOTAL SPINAL CORRECTIONDepuy, Inc.

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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