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FDA 510(k)

PARAGON POSTERIOR SPINAL SYSTEM

K-Number: K920546 · 1993-01-21

ApplicantSofamor Danek Mfg., Inc.
Decision Date1993-01-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PARAGON POSTERIOR SPINAL SYSTEM 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 1993-01-21 under 510(k) number K920546. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PARAGON POSTERIOR SPINAL SYSTEM?

PARAGON POSTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K920546.

When did PARAGON POSTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

PARAGON POSTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1993-01-21, under 510(k) number K920546.

Who is the listed applicant for PARAGON POSTERIOR SPINAL SYSTEM?

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 PARAGON POSTERIOR SPINAL SYSTEM?

The FDA product code for PARAGON POSTERIOR SPINAL SYSTEM 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.

K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSK930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYK932029TSRH SPINAL SCREWSK922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMK930807SENTRY ANTERIOR SPINAL SYSTEMK930710SENTRY POSTERIOR SPINAL SYSTEM

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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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