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FDA 510(k)

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX

K-Number: K080074 · 2008-02-14

ApplicantAce Surgical Supply Co., Inc.
Decision Date2008-02-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX is the device name listed in this FDA 510(k) record. The listed applicant is Ace Surgical Supply Co., Inc.. It received FDA 510(k) clearance on 2008-02-14 under 510(k) number K080074. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX?

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K080074.

When did ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX receive FDA 510(k) clearance?

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX received FDA 510(k) clearance on 2008-02-14, under 510(k) number K080074.

Who is the listed applicant for ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX?

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

What is the FDA product code for ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX?

The FDA product code for ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX is DZE.

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Other records listing Ace Surgical Supply Co., 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.

K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMK092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OXK073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XXK061397ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, MK051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATEK041759ACE CONNECT INTERNAL CONNECTION

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Related Devices (Code: DZE)

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K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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