FDA.reportPublic FDA data

Facet Screw System

Primary DI
00815362023686
Brand
Facet Screw System
Company
PRECISION SPINE, INC.
Model
50-0013
Catalog number
50-0013
Device description
Facet Screw Tray (Empty)
Published
2019-04-01
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
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130863000FACET SCREW SYSTEMSpinal USA2013-08-09MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815362023686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815362023686008153620236868153620236860815362023686

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
00840019970907MD-Vue™ Lateral Access System54-TA-050054-TA-05002026-05-01
00840019970914MD-Vue™ Lateral Access System54-TA-060054-TA-06002026-05-01
00840019970921MD-Vue™ Lateral Access System54-TA-070054-TA-07002026-05-01
00840019970938MD-Vue™ Lateral Access System54-TA-080054-TA-08002026-05-01
00840019970945MD-Vue™ Lateral Access System54-TA-090054-TA-09002026-05-01
00840019970952MD-Vue™ Lateral Access System54-TA-100054-TA-10002026-05-01
00840019971133Reform Ti Modular39-SF-654539-SF-65452026-01-13
00840019971140Reform Ti Modular39-SF-655039-SF-65502026-01-13
00840019971157Reform Ti Modular39-SF-655539-SF-65552026-01-13
00840019971164Reform Ti Modular39-SF-656039-SF-65602026-01-13
00840019971171Reform Ti Modular39-SF-753039-SF-75302026-01-13
00840019971188Reform Ti Modular39-SF-753539-SF-75352026-01-13
00840019971195Reform Ti Modular39-SF-754039-SF-75402026-01-13
00840019971201Reform Ti Modular39-SF-754539-SF-75452026-01-13
00840019971218Reform Ti Modular39-SF-755039-SF-75502026-01-13
00840019971225Reform Ti Modular39-SF-755539-SF-75552026-01-13
00840019971232Reform Ti Modular39-SF-756039-SF-75602026-01-13
00840019971249Reform Ti Modular39-SF-757039-SF-75702026-01-13
00840019971256Reform Ti Modular39-SF-758039-SF-75802026-01-13
00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800039819909FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819916FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819923FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819930FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819947FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819954FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819961FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819978FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819985FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819992FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820004FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820011FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820028FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820035FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820042FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820059FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820318FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820325FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820332FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820349FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039821391FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823739FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823746FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823753FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823760FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823777FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823784FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823791FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823807FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823814FasetDIOMEDICAL CO.,LTD.MRW2019-02-08