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FDA 510(k)

ROGOZINSKI THORACOLUMBAR SPINAL ROD

K-Number: K954696 · 1996-03-11

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-03-11
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ROGOZINSKI THORACOLUMBAR SPINAL ROD is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K954696. 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 ROGOZINSKI THORACOLUMBAR SPINAL ROD?

ROGOZINSKI THORACOLUMBAR SPINAL ROD is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K954696.

When did ROGOZINSKI THORACOLUMBAR SPINAL ROD receive FDA 510(k) clearance?

ROGOZINSKI THORACOLUMBAR SPINAL ROD received FDA 510(k) clearance on 1996-03-11, under 510(k) number K954696.

Who is the listed applicant for ROGOZINSKI THORACOLUMBAR SPINAL ROD?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROGOZINSKI THORACOLUMBAR SPINAL ROD?

The FDA product code for ROGOZINSKI THORACOLUMBAR SPINAL ROD is KWP.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP 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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