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FDA 510(k)

SURGICAL HEAD SUPPORT

K-Number: K861915 · 1986-05-30

ApplicantTreace Medical, Inc.
Decision Date1986-05-30
Product CodeCCX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SURGICAL HEAD SUPPORT 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 1986-05-30 under 510(k) number K861915. The device is classified under product code CCX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL HEAD SUPPORT?

SURGICAL HEAD SUPPORT is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Treace Medical, Inc.. The 510(k) number is K861915.

When did SURGICAL HEAD SUPPORT receive FDA 510(k) clearance?

SURGICAL HEAD SUPPORT received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861915.

Who is the listed applicant for SURGICAL HEAD SUPPORT?

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 SURGICAL HEAD SUPPORT?

The FDA product code for SURGICAL HEAD SUPPORT is CCX.

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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: CCX)

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.

K943837CHIN UPEdward CardenK932305VILA-COOKE(TM) ANESTHESIA PILLOWSharn, Inc.K934235SNIFF POSITION PILLOWAmerican Medical Development, Inc.K833022AIR UTERINE DISPLACER-AUD 120Scientific Sales Intl., Inc.K821838VARI-SUPPORT LOW BACK POSTURE PILLOWBody Therapeutics, Inc.K810035PRENATAL SUPPORT PILLOWSupportech, 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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