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FDA 510(k)

METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM

K-Number: K022886 · 2002-11-25

ApplicantOsteomed Corp.
Decision Date2002-11-25
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 2002-11-25 under 510(k) number K022886. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM?

METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-25. The listed applicant is Osteomed Corp.. The 510(k) number is K022886.

When did METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM receive FDA 510(k) clearance?

METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM received FDA 510(k) clearance on 2002-11-25, under 510(k) number K022886.

Who is the listed applicant for METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM?

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

What is the FDA product code for METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM?

The FDA product code for METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM is KWH.

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Other records listing Osteomed 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEMK012486OSTEOMED BIORESORBABLE FIXATION SYSTEM

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Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, 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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