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FDA 510(k)

TSRH L CONNECTOR -- MODIFICATION

K-Number: K923339 · 1992-10-27

ApplicantSofamor Danek Mfg., Inc.
Decision Date1992-10-27
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TSRH L CONNECTOR -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1992-10-27 under 510(k) number K923339. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSRH L CONNECTOR -- MODIFICATION?

TSRH L CONNECTOR -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-10-27. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K923339.

When did TSRH L CONNECTOR -- MODIFICATION receive FDA 510(k) clearance?

TSRH L CONNECTOR -- MODIFICATION received FDA 510(k) clearance on 1992-10-27, under 510(k) number K923339.

Who is the listed applicant for TSRH L CONNECTOR -- MODIFICATION?

The FDA 510(k) record lists Sofamor Danek Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSRH L CONNECTOR -- MODIFICATION?

The FDA product code for TSRH L CONNECTOR -- MODIFICATION is KWP.

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Other records listing Sofamor Danek Mfg., Inc. 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.

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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