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FDA 510(k)

ROGOZINSKI SPINAL ROD SYSTEM SCREW

K-Number: K930298 · 1995-06-14

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-06-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROGOZINSKI SPINAL ROD SYSTEM SCREW 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 1995-06-14 under 510(k) number K930298. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROGOZINSKI SPINAL ROD SYSTEM SCREW?

ROGOZINSKI SPINAL ROD SYSTEM SCREW is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K930298.

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

ROGOZINSKI SPINAL ROD SYSTEM SCREW received FDA 510(k) clearance on 1995-06-14, under 510(k) number K930298.

Who is the listed applicant for ROGOZINSKI SPINAL ROD SYSTEM SCREW?

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 SPINAL ROD SYSTEM SCREW?

The FDA product code for ROGOZINSKI SPINAL ROD SYSTEM SCREW is MNH. This falls under the ENT category.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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