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FDA 510(k)

OSTEOMED GREAT TOE SYSTEM

K-Number: K922211 · 1993-11-09

ApplicantOsteomed Corp.
Decision Date1993-11-09
Product CodeLZJ
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEOMED GREAT TOE 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 1993-11-09 under 510(k) number K922211. The device is classified under product code LZJ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSTEOMED GREAT TOE SYSTEM?

OSTEOMED GREAT TOE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-11-09. The listed applicant is Osteomed Corp.. The 510(k) number is K922211.

When did OSTEOMED GREAT TOE SYSTEM receive FDA 510(k) clearance?

OSTEOMED GREAT TOE SYSTEM received FDA 510(k) clearance on 1993-11-09, under 510(k) number K922211.

Who is the listed applicant for OSTEOMED GREAT TOE 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 OSTEOMED GREAT TOE SYSTEM?

The FDA product code for OSTEOMED GREAT TOE SYSTEM is LZJ.

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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 SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

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Related Devices (Code: LZJ)

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.

K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYAscension Orthopedics, Inc.K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMerete Medical GmbHK950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)Acu Med, Inc.K941650TOTAL TOE SYSTEM IIBiomet, Inc.K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.K920446TOTAL TOE SYSTEMBiomet, 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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