FDA.reportPublic FDA data

RAAS Cranial Plating System

Primary DI
M6862900I10220
Brand
RAAS Cranial Plating System
Company
ALLIANCE PARTNERS LLC
Model
2900I-1022
Catalog number
2900I-1022
Device description
Cranial Large Gap Plate
Published
2015-09-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWOPlate, cranioplasty, preformed, alterable
GXRCOVER, BURR HOLE
HBWFASTENER, PLATE, CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6862900I10220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Height0.5Millimeter
Length49Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(210)314-2525info@alliance-spine.com

Regulatory Flags#

DUNS number
962768169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6861412T3000Alamo C1412T-3001412T-3002016-09-23
M6862100T19010Alamo P, Alamo T2100T-19012100T-19012017-01-01
M6862100T19020Alamo P, Alamo T2100T-19022100T-19022017-01-01
M6863100T12000Nakoma3100T-12003100T-12002016-09-23
M6863100I10000Nakoma-SL ACP System3100I-10003100I-10002015-09-14
M6863100I10010Nakoma-SL ACP System3100I-10013100I-10012015-09-14
M6863100I10020Nakoma-SL ACP System3100I-10023100I-10022015-09-14
M6863100I10030Nakoma-SL ACP System3100I-10033100I-10032015-09-14
M6863100I10040Nakoma-SL ACP System3100I-10043100I-10042015-09-14
M6863100I10050Nakoma-SL ACP System3100I-10053100I-10052015-09-14
M6863100I10060Nakoma-SL ACP System3100I-10063100I-10062015-09-14
M6863100I20000Nakoma-SL ACP System3100I-20003100I-20002015-09-14
M6863100I20010Nakoma-SL ACP System3100I-20013100I-20012015-09-14
M6863100I20020Nakoma-SL ACP System3100I-20023100I-20022015-09-14
M6863100I20030Nakoma-SL ACP System3100I-20033100I-20032015-09-14
M6863100I20040Nakoma-SL ACP System3100I-20043100I-20042015-09-14
M6863100I20050Nakoma-SL ACP System3100I-20053100I-20052015-09-14
M6863100I20060Nakoma-SL ACP System3100I-20063100I-20062015-09-14
M6863100I20070Nakoma-SL ACP System3100I-20073100I-20072015-09-14
M6863100I20080Nakoma-SL ACP System3100I-20083100I-20082015-09-14

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Primary DI, Brand, Company table
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