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FDA 510(k)

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)

K-Number: K950864 · 1995-07-31

ApplicantAcu Med, Inc.
Decision Date1995-07-31
Product CodeLZJ
DecisionSubstantially Equivalent

Device Summary

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K950864. The device is classified under product code LZJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)?

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Acu Med, Inc.. The 510(k) number is K950864.

When did GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) receive FDA 510(k) clearance?

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) received FDA 510(k) clearance on 1995-07-31, under 510(k) number K950864.

Who is the listed applicant for GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)?

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

What is the FDA product code for GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)?

The FDA product code for GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) is LZJ.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK980103ACUMED SUTURE ANCHOR

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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 GmbHK941650TOTAL TOE SYSTEM IIBiomet, 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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