Slimplicity Plus Anterior Cervical Plating System 66-SF-4520

GUDID 00840019915786

Fixed Screws 4.5mm x 20mm

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID00840019915786
NIH Device Record Key687fe392-9e39-426a-ab6b-ad020aa35917
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimplicity Plus Anterior Cervical Plating System
Version Model Number66-SF-4520
Catalog Number66-SF-4520
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 Usetrue
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
GS100840019915786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

[00840019915786]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-09
Device Publish Date2019-03-28

On-Brand Devices [Slimplicity Plus Anterior Cervical Plating System]

00840019931007Plate Bender
00840019921039Slimplicity® Plus Self Drilling Screw Caddy (Empty)
00840019921022Slimplicity® Self Drilling Screw Caddy (Empty)
00840019921015Slimplicity® Plus 3 & 4 Level Plate Caddy (Empty)
00840019920988Slimplicity® Plus Sterilization Case (Empty)
00840019920971Temporary Fixation Pin
00840019920964Drill - 16mm
00840019920957Drill - 14mm
00840019920940Drill - 12mm
00840019920933Drill - 10mm
00840019916332Slimplicity Plus ACP - 4 level, 81mm
00840019916325Slimplicity Plus ACP - 4 level, 77mm
00840019916318Slimplicity Plus ACP - 4 level, 73mm
00840019916301Slimplicity Plus ACP - 4 level, 69mm
00840019916288Slimplicity Plus ACP - 4 level, 61mm
00840019916271Slimplicity Plus ACP - 4 level, 57mm
00840019916264Slimplicity Plus ACP - 3 level, 67mm
00840019916257Slimplicity Plus ACP - 3 level, 64mm
00840019916233Slimplicity Plus ACP - 3 level, 58mm
00840019916226Slimplicity Plus ACP - 3 level, 55mm
00840019916219Slimplicity Plus ACP - 3 level, 52mm
00840019916202Slimplicity Plus ACP - 3 level, 49mm
00840019916196Slimplicity Plus ACP - 3 level, 46mm
00840019916189Slimplicity Plus ACP - 3 level, 43mm
00840019916172Slimplicity Plus ACP - 2 level, 47mm
00840019916165Slimplicity Plus ACP - 2 level, 44mm
00840019916141Slimplicity Plus ACP - 2 level, 38mm
00840019916134Slimplicity Plus ACP - 2 level, 35mm
00840019916127Slimplicity Plus ACP - 2 level, 32mm
00840019916110Slimplicity Plus ACP - 2 level, 29mm
00840019916103Slimplicity Plus ACP - 2 level, 27mm
00840019916097Slimplicity Plus ACP - 2 level, 25mm
00840019916080Slimplicity Plus ACP - 1 level, 26mm
00840019916073Slimplicity Plus ACP - 1 level, 24mm
00840019916059Slimplicity Plus ACP - 1 level, 20mm
00840019916042Slimplicity Plus ACP - 1 level, 18mm
00840019916035Slimplicity Plus ACP - 1 level, 16mm
00840019916028Slimplicity Plus ACP - 1 level, 14mm
00840019916011Slimplicity Plus ACP - 1 level, 12mm
00840019916004Slimplicity Plus ACP - 1 level, 10mm
00840019915991Variable Blunt Screws 4.5mm x 20mm
00840019915977Variable Blunt Screws 4.5mm x 18mm
00840019915946Variable Screws 4.5mm x 16mm
00840019915939Variable Blunt Screws 4.5mm x 14mm
00840019915922Variable Screws 4.5mm x 14mm
00840019915915Variable Blunt Screws 4.5mm x 12mm
00840019915908Variable Screws 4.5mm x 12mm
00840019915892Variable Blunt Screws 4mm x 20mm
00840019915878Variable Blunt Screws 4mm x 18mm
00840019915861Variable Screws 4mm x 18mm
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