FDA.reportPublic FDA data

Alamo C

Primary DI
M6861412T2030
Brand
Alamo C
Company
ALLIANCE PARTNERS LLC
Model
1412T-203
Catalog number
1412T-203
Device description
Double Ended Trial/Rasp Instrument
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTRRASP
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1
HWTTemplateOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112361000
K173128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112361000ALAMO CAlliance Partners, LLC2011-11-30ODP
K173128000Alamo® CAlliance Partners, LLC2018-03-22ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6861412T2030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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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04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
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04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
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04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
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