FDA.reportPublic FDA data

Vault C ACDF System

Primary DI
00840019916585
Brand
Vault C ACDF System
Company
PRECISION SPINE, INC.
Model
37-TN-7612
Catalog number
37-TN-7612
Device description
Trial, 7° Lordosis, 16x14 - 11/12mm
Published
2019-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019916585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019916585008400199165858400199165850840019916585

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934909Reform Ti39-TD-555539-TD-55552019-10-04
00840019934916Reform Ti39-TD-556039-TD-55602019-10-04
00840019934923Reform Ti39-TD-652539-TD-65252019-10-04
00840019934930Reform Ti39-TD-653039-TD-65302019-10-04
00840019934947Reform Ti39-TD-653539-TD-65352019-10-04
00840019934954Reform Ti39-TD-654039-TD-65402019-10-04
00840019934961Reform Ti39-TD-654539-TD-65452019-10-04
00840019934978Reform Ti39-TD-655039-TD-65502019-10-04
00840019934985Reform Ti39-TD-655539-TD-65552019-10-04
00840019934992Reform Ti39-TD-656039-TD-65602019-10-04
00840019935005Reform Ti39-TD-753039-TD-75302019-10-04
00840019935012Reform Ti39-TD-753539-TD-75352019-10-04
00840019935029Reform Ti39-TD-754039-TD-75402019-10-04
00840019935036Reform Ti39-TD-754539-TD-75452019-10-04
00840019935043Reform Ti39-TD-755039-TD-75502019-10-04
00840019935050Reform Ti39-TD-755539-TD-75552019-10-04
00840019935067Reform Ti39-TD-756039-TD-75602019-10-04
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
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