FDA.reportPublic FDA data

Vault C ACDF System

Primary DI
00840019936316
Brand
Vault C ACDF System
Company
PRECISION SPINE, INC.
Model
37-BK-0104
Catalog number
37-BK-0104
Device description
Standard Implant Kit + 18x15 implants and trials + Directional Blade
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132029000VAULT-C INTERVERTEBRAL BODY FUSION DEVICESpinal USA2013-11-25OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019936316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019936316008400199363168400199363160840019936316

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019922647Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0002HXI-48-00022019-03-27
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19
00840019978248Reform Ti39-TM-556039-TM-55602026-10-19
00840019978255Reform Ti39-TM-652539-TM-65252026-10-19
00840019978262Reform Ti39-TM-653039-TM-65302026-10-19
00840019978279Reform Ti39-TM-653539-TM-65352026-10-19
00840019978286Reform Ti39-TM-654039-TM-65402026-10-19
00840019978293Reform Ti39-TM-654539-TM-65452026-10-19
00840019978309Reform Ti39-TM-655039-TM-65502026-10-19
00840019978316Reform Ti39-TM-655539-TM-65552026-10-19
00840019978323Reform Ti39-TM-656039-TM-65602026-10-19
00840019978330Reform Ti39-TM-753039-TM-75302026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B0623400141205Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141206Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141207Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141208Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141209Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141210Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141211Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141212Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161305Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161306Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161307Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161308Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161309Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161310Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161311Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161312Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181405Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181406Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181407Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181408Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181409Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181410Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181411Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181412Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205012Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205014Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205016Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205018Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28