Slimplicity Anterior Cervical Plate System SDF4020

GUDID 00840019905039

4.0mm x 20mm SD Fixed Screw

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 ID00840019905039
NIH Device Record Key8f048ff6-fbde-4497-b498-a72cdc769724
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimplicity Anterior Cervical Plate System
Version Model NumberSDF4020
Catalog NumberSDF4020
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019905039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

[00840019905039]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-19
Device Publish Date2019-04-11

On-Brand Devices [Slimplicity Anterior Cervical Plate System]

00840019931038Slimplicity Driver, AO Connect, 6.4"
00840019920926Slimplicity ACP System Kit
00840019920902Cervical Distraction Pin Caspar 18mm
00840019920896Cervical Distraction Pin Caspar 16mm
00840019920889Cervical Distraction Pin Caspar 14mm
00840019920872Cervical Distraction Pin Caspar 12mm
00840019920865Drill 3.0 x 16mm
00840019920858Drill 3.0 x 14mm
00840019920841Drill 3.0 x 12mm
00840019920827Bone Awl
00840019920810Variable Drill Guide
00840019920797Cervical Plate Bender
00840019920773ACP Lock/Unlock Tool
00840019920766ACP Locking Tool
00840019931021Slimplicity Driver, AO Connect, 5.5"
00840019920919Slimplicity ACP Sterilization Case (Empty)
00840019920834Fixation Pin (Bone Tack)
00840019920803Fixed Drill Guide
008400199207802.5mm Shaft Tapered Hex
0081536202143918mm Drill
0081536202142216mm Drill
0081536202141514mm Drill
0081536202140812mm Drill
00815362021392Bone Awl
00815362021385Bone Tap
00815362021378Plate Bender
00815362021361Lock/Unlock Tool
008153620213544.5 x 18mm Variable Screw
008153620213474.5 x 16mm Variable Screw
008153620213304.5 x 14mm Variable Screw
008153620213234.5 x 12mm Variable Screw
008153620213164.5 x 18mm Fixed Screw
008153620213094.5 x 16mm Fixed Screw
008153620212934.5 x 14mm Fixed Screw
008153620212864.5 x 12mm Fixed Screw
008153620212792 Level 46mm Plate
008153620212622 Level 44mm Plate
008153620212552 Level 42mm Plate
008153620212482 Level 40mm Plate
008153620212312 Level 38mm Plate
008153620212242 Level 36mm Plate
008153620212172 Level 34mm Plate
008153620212002 Level 32mm Plate
008153620211942 Level 30mm Plate
008153620211872 Level 28mm Plate
008153620211702 Level 26mm Plate
008153620211631 Level 28mm Plate
008153620211561 Level 26mm Plate
008153620211491 Level 24mm Plate
008153620211321 Level 22mm Plate
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