Aptitude Anterior Cervical Plate System

GUDID B648C1544012FST0

Fixed Self-Tapping Screw, 4.0 x 12mm

CURITEVA, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device IDB648C1544012FST0
NIH Device Record Key8aab39ed-ba4b-4a27-a275-65f038fe48ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameAptitude Anterior Cervical Plate System
Version Model NumberC154-4012-FST
Company DUNS074575332
Company NameCURITEVA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB648C1544012FST0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

[B648C1544012FST0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-17
Device Publish Date2019-01-04

On-Brand Devices [Aptitude Anterior Cervical Plate System]

B648C16402420Midline Anterior Cervical Plate, Two-Level, 42mm
B648C16402400Midline Anterior Cervical Plate, Two-Level, 40mm
B648C16402380Midline Anterior Cervical Plate, Two-Level, 38mm
B648C16402360Midline Anterior Cervical Plate, Two-Level, 36mm
B648C16402340Midline Anterior Cervical Plate, Two-Level, 34mm
B648C16402320Midline Anterior Cervical Plate, Two-Level, 32mm
B648C16402300Midline Anterior Cervical Plate, Two-Level, 30mm
B648C16402280Midline Anterior Cervical Plate, Two-Level, 28mm
B648C16402260Midline Anterior Cervical Plate, Two-Level, 26mm
B648C16401260Midline Anterior Cervical Plate, One-Level, 26mm
B648C16401240Midline Anterior Cervical Plate, One-Level, 24mm
B648C16401220Midline Anterior Cervical Plate, One-Level, 22mm
B648C16401200Midline Anterior Cervical Plate, One-Level, 20mm
B648C16401180Midline Anterior Cervical Plate, One-Level, 18mm
B648C16401160Midline Anterior Cervical Plate, One-Level, 16mm
B648C16401140Midline Anterior Cervical Plate, One-Level, 14mm
B648C16401120Midline Anterior Cervical Plate, One-Level, 12mm
B648C1544518VST0Variable Self-Tapping Rescue Screw, 4.5 x 18mm
B648C1544518FST0Fixed Self-Tapping Rescue Screw, 4.5 x 18mm
B648C1544516VST0Variable Self-Tapping Rescue Screw, 4.5 x 16mm
B648C1544516FST0Fixed Self-Tapping Rescue Screw, 4.5 x 16mm
B648C1544514VST0Variable Self-Tapping Rescue Screw, 4.5 x 14mm
B648C1544514FST0Fixed Self-Tapping Rescue Screw, 4.5 x 14mm
B648C1544512VST0Variable Self-Tapping Rescue Screw, 4.5 x 12mm
B648C1544512FST0Fixed Self-Tapping Rescue Screw, 4.5 x 12mm
B648C1544018VST0Variable Self-Tapping Screw, 4.0 x 18mm
B648C1544018VSD0Variable Self-Drilling Screw, 4.0 x 18mm
B648C1544018FST0Fixed Self-Tapping Screw, 4.0 x 18mm
B648C1544018FSD0Fixed Self-Drilling Screw, 4.0 x 18mm
B648C1544016VST0Variable Self-Tapping Screw, 4.0 x 16mm
B648C1544016VSD0Variable Self-Drilling Screw, 4.0 x 16mm
B648C1544016FST0Fixed Self-Tapping Screw, 4.0 x 16mm
B648C1544016FSD0Fixed Self-Drilling Screw, 4.0 x 16mm
B648C1544014VST0Variable Self-Tapping Screw, 4.0 x 14mm
B648C1544014VSD0Variable Self-Drilling Screw, 4.0 x 14mm
B648C1544014FST0Fixed Self-Tapping Screw, 4.0 x 14mm
B648C1544014FSD0Fixed Self-Drilling Screw, 4.0 x 14mm
B648C1544012VST0Variable Self-Tapping Screw, 4.0 x 12mm
B648C1544012VSD0Variable Self-Drilling Screw, 4.0 x 12mm
B648C1544012FST0Fixed Self-Tapping Screw, 4.0 x 12mm
B648C1544012FSD0Fixed Self-Drilling Screw, 4.0 x 12mm
B648C15404840Anterior Cervical Plate, Four-Level, 84mm
B648C15404800Anterior Cervical Plate, Four-Level, 80mm
B648C15404760Anterior Cervical Plate, Four-Level, 76mm
B648C15404720Anterior Cervical Plate, Four-Level, 72mm
B648C15404680Anterior Cervical Plate, Four-Level, 68mm
B648C15404640Anterior Cervical Plate, Four-Level, 64mm
B648C15404600Anterior Cervical Plate, Four-Level, 60mm
B648C15403630Anterior Cervical Plate, Three-Level, 63mm
B648C15403600Anterior Cervical Plate, Three-Level, 60mm
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