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FDA 510(k)

TOTAL TOE SYSTEM II

K-Number: K941650 · 1994-12-19

ApplicantBiomet, Inc.
Decision Date1994-12-19
Product CodeLZJ
DecisionSubstantially Equivalent

Device Summary

TOTAL TOE SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-12-19 under 510(k) number K941650. The device is classified under product code LZJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL TOE SYSTEM II?

TOTAL TOE SYSTEM II is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Biomet, Inc.. The 510(k) number is K941650.

When did TOTAL TOE SYSTEM II receive FDA 510(k) clearance?

TOTAL TOE SYSTEM II received FDA 510(k) clearance on 1994-12-19, under 510(k) number K941650.

Who is the listed applicant for TOTAL TOE SYSTEM II?

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

What is the FDA product code for TOTAL TOE SYSTEM II?

The FDA product code for TOTAL TOE SYSTEM II is LZJ.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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.K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.K922211OSTEOMED GREAT TOE SYSTEMOsteomed Corp.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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