Accufit Lateral Plate System 58-LP-0034

GUDID 00840019904476

34mm Plate

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840019904476
NIH Device Record Keyf2dad8b8-b935-426a-9dd9-a471e544d8f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccufit Lateral Plate System
Version Model Number58-LP-0034
Catalog Number58-LP-0034
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
GS100840019904476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

[00840019904476]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-15
Device Publish Date2019-04-05

On-Brand Devices [Accufit Lateral Plate System]

00840019919876AccuFit® LP Case
00840019919852Lock Unlock Driver
00840019919845Locking Screw Driver
00840019919814Plate Holder
008400199198075in-lb Torque Limiting Handle
00840019919791Ratcheting AO Handle
00840019919784Adjustable Guide
00840019919777Angled Trocar Awl
00840019919760Flexible Trocar Awl
00840019919746Flexible Bevel Awl
00840019919739Bevel Awl
00840019919722Flexible Drill
00840019919715Drill
008400199198697.5mm Up-biting Rongeur, Disc 13"
00840019919838Flexible Bone Screw Driver
00840019919821Bone Screw Driver
00840019919753Trocar Awl
00840019904643Locking Screw
00840019904636Ø6.5mm Variable Screw, 60mm
00840019904629Ø6.5mm Variable Screw, 55mm
00840019904612Ø6.5mm Variable Screw, 50mm
00840019904605Ø6.5mm Variable Screw, 45mm
00840019904599Ø6.5mm Variable Screw, 40mm
00840019904582Ø6.5mm Variable Screw, 35mm
0084001990457558-VS-6530
00840019904568Ø5.5mm Variable Screw, 60mm
00840019904551Ø5.5mm Variable Screw, 55mm
00840019904544Ø5.5mm Variable Screw, 50mm
00840019904537Ø5.5mm Variable Screw, 45mm
00840019904520Ø5.5mm Variable Screw, 40mm
00840019904513Ø5.5mm Variable Screw, 35mm
00840019904506Ø5.5mm Variable Screw, 30mm
0084001990449038mm Plate
0084001990448336mm Plate
0084001990447634mm Plate
0084001990446932mm Plate
0084001990445230mm Plate
00815362025147Ø5.5mm Variable Screw, 25mm
00815362023334Ø6.5mm Variable Screw, 25mm
00840019936491Instrument & Implant Kit
00840019967457AccuFit 4 Hole Lateral Plate Kit
00840019967440AccuFit 4 Hole Lateral Plate Caddy
00840019965910Instrument & Implant Kit - 2 Hole Plate
00840019965903AccuFit 2 Hole Lateral Plate Kit
00840019965897AccuFit 2 Hole Lateral Plate Caddy
008400199658802 Hole DTS Drill - 25mm
008400199658732 Hole 7° DTS Guide Plate Holder
008400199658662 Hole Forceps Plate Holder
00840019965859AccuFit 2 Hole Lateral Plate - 36mm
00840019965842AccuFit 2 Hole Lateral Plate - 34mm
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