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FDA 510(k)

ROGOZINSKI SPINAL SYSTEM

K-Number: K884263 · 1988-12-29

ApplicantRichards Medical Co., Inc.
Decision Date1988-12-29
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROGOZINSKI SPINAL SYSTEM 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 1988-12-29 under 510(k) number K884263. 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 ROGOZINSKI SPINAL SYSTEM?

ROGOZINSKI SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K884263.

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

ROGOZINSKI SPINAL SYSTEM received FDA 510(k) clearance on 1988-12-29, under 510(k) number K884263.

Who is the listed applicant for ROGOZINSKI SPINAL SYSTEM?

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?

The FDA product code for ROGOZINSKI SPINAL SYSTEM 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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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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