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FDA 510(k)

ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS

K-Number: K896106 · 1990-06-25

ApplicantRichards Medical Co., Inc.
Decision Date1990-06-25
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1990-06-25 under 510(k) number K896106. 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 SPINAL SYSTEM, ADD'L COMPONENTS?

ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS is a medical device that received FDA 510(k) clearance on 1990-06-25. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K896106.

When did ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS receive FDA 510(k) clearance?

ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS received FDA 510(k) clearance on 1990-06-25, under 510(k) number K896106.

Who is the listed applicant for ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS?

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

What is the FDA product code for ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS?

The FDA product code for ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS is KWP.

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Other records listing Richards Medical Co., 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.

K900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZESK895242PAPPAS TRI-FLANGE VENTILATION TUBE

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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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