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FDA 510(k)

TREACE DRILL SYSTEM

K-Number: K862807 · 1986-08-15

ApplicantTreace Medical, Inc.
Decision Date1986-08-15
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TREACE DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1986-08-15 under 510(k) number K862807. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREACE DRILL SYSTEM?

TREACE DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is Treace Medical, Inc.. The 510(k) number is K862807.

When did TREACE DRILL SYSTEM receive FDA 510(k) clearance?

TREACE DRILL SYSTEM received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862807.

Who is the listed applicant for TREACE DRILL SYSTEM?

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

What is the FDA product code for TREACE DRILL SYSTEM?

The FDA product code for TREACE DRILL SYSTEM is ERL.

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Other records listing Treace Medical, 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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