RCS Anterior Buttress Plate System 21-1050-CA

GUDID 00840019936224

Buttress Plate Tray 1 Assembly

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840019936224
NIH Device Record Keydc5d0524-d4a2-4def-b8a1-f93591b75d2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRCS Anterior Buttress Plate System
Version Model Number21-1050-CA
Catalog Number21-1050-CA
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019936224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


[00840019936224]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-06
Device Publish Date2019-08-29

On-Brand Devices [RCS Anterior Buttress Plate System]

00815362021071Buttress Plate Case
00815362021057RCS Buttress Screwdriver Straight 3.5mm
0081536202104022-9002
00815362021033RCS Buttress Inserter Tool
00815362021026Self Drilling Screw 5.5mm x 35mm
00815362021019Self Drilling Screw 5.5mm x 30mm
00815362021002Self Drilling Screw 5.5mm x 25mm
00815362020999Self Drilling Screw 5.5mm x 20mm
00815362020982RCS Buttress Plate 30mm
00815362020975RCS Buttress Plate 25mm
00840019936224Buttress Plate Tray 1 Assembly

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