CERVICAL BRACE— 510(k) K822780

Substantially Equivalent

Jerome Medical

FDA 510(k) clearance K822780 for CERVICAL BRACE, Substantially Equivalent on 1982-10-06. Applicant: Jerome Medical. Device class: 2.

Clearance details

Applicant: Jerome Medical
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1982-09-14
Decision date: 1982-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Jerome Medical

K051918 — RESOLVE OPEN BACK HALO RINGS2005-08-17
K930021 — J TONGS1995-12-06
K930153 — SYSTEM III HALO RING1993-08-06
K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE1988-09-30
K870053 — TORQUEDRIVER WRENCH1987-03-11

Recalls naming K822780

K-number listed on FDA's recall record

Z-0997-2019 — Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PKClass II·Terminated·Ossur Americas·20180621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K822780.

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