Table, Surgical With Orthopedic Accessories, Manual

Device Code: 5692

Product Code(s): JEB

Device Classification Information

Device Type ID5692
Device NameTable, Surgical With Orthopedic Accessories, Manual
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4950 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJEB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5692
DeviceTable, Surgical With Orthopedic Accessories, Manual
Product CodeJEB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair And Accessories.
CFR Regulation Number878.4950 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Allen Medical Systems
II Feb-20-2018
2
Schaerer Medical USA Inc
II Nov-08-2016
3
Zimmer Biomet, Inc.
II Feb-28-2018
TPLC Last Update: 2019-04-02 21:10:55

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