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FDA 510(k)

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)

K-Number: K091725 · 2009-11-09

ApplicantU&I Corp.
Decision Date2009-11-09
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corp.. It received FDA 510(k) clearance on 2009-11-09 under 510(k) number K091725. 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 PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)?

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) is a medical device that received FDA 510(k) clearance on 2009-11-09. The listed applicant is U&I Corp.. The 510(k) number is K091725.

When did PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) receive FDA 510(k) clearance?

PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) received FDA 510(k) clearance on 2009-11-09, under 510(k) number K091725.

Who is the listed applicant for PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)?

The FDA 510(k) record lists U&I Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)?

The FDA product code for PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) is MNH. This falls under the ENT category.

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Other records listing U&I Corp. 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.

K120419DYNA LOCKING ANKLE NAILK112240DYNA LOCKING CANNULATED SCREWK102367OPTIGEN TOTAL KNEE SYSTEMK093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820K092771DYNA LOCKING IM NAILK061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

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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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