FDA.reportPublic FDA data

Facilis™ Spinal System

Primary DI
04718251506238
Brand
Facilis™ Spinal System
Company
BAUI BIOTECH CO. LTD.
Model
320-5535
Device description
Smooth Rod: 5.5*350
Published
2020-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04718251506238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04718251506238047182515062384718251506238

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
656775504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04718251502254Facilis™ Spinal System156-1216*2025-01-09
04719883860842NOVA Minimally Invasive System156-12162025-01-09
04710577040144Facilis™ Spinal System156-12162020-02-14
04710577040939Orthopedic manual surgical instrument409-0813B2025-01-15
04710577040953Orthopedic manual surgical instrument405-11032025-01-15
04710577041677Orthopedic manual surgical instrument409-3114A2025-01-15
04710577041691Orthopedic manual surgical instrument409-0829B2025-01-15
04710577043282Orthopedic manual surgical instrument405-0801B2025-01-15
04710577043374Orthopedic manual surgical instrument409-0901B2025-01-15
04710577043381Orthopedic manual surgical instrument409-14052025-01-15
04710577043398Orthopedic manual surgical instrument409-14042025-01-15
04710577043404Orthopedic manual surgical instrument409-14032025-01-15
04710577043473Orthopedic manual surgical instrument409-0829F2025-01-15
04710577043503Orthopedic manual surgical instrument406-0103D2025-01-15
04710577043510Orthopedic manual surgical instrument409-0836B2025-01-15
04710577043558Orthopedic manual surgical instrument405-0502A2025-01-15
04710577043619Orthopedic manual surgical instrument405-0904J2025-01-15
04710577044616Orthopedic manual surgical instrument406-0504B2025-01-15
04712899253110Orthopedic manual surgical instrument406-01072025-01-15
04712899253158Orthopedic manual surgical instrument406-01032025-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationNKB2016-09-02