MALLET, SURGICAL— 510(k) K882349

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K882349 for MALLET, SURGICAL, Substantially Equivalent on 1988-06-23. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code HXL
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-06-07
Decision date: 1988-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXL

K872209 — ARTHROPLASTY MALLET1987-06-23
K871195 — MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.1987-04-06

More clearances from Treace Medical, Inc.

K883727 — BUCKET PROSTHESIS PORP1989-01-13
K874779 — BIPOLATOR 501988-01-29
K873154 — TREACE MAGNUM OTO-TOOL SYSTEM1987-09-04
K872000 — EYE GARD1987-07-21
K870765 — CANNULATED INSTRUMENT CLEANERS1987-05-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.