FDA.reportPublic FDA data

Perfix™ Iliac Screw System

Primary DI
08800015931564
Brand
Perfix™ Iliac Screw System
Company
CG MedTech Co.,Ltd.
Model
SL0223
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132218000PERFIX ILIAC SCREW SYSTEMU&I Corporation2013-12-17MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800015931564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800015931564088000159315648800015931564

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27
08800247359945UniSpace® TPLIF CageTU02202026-06-27
08800247359952UniSpace® TPLIF CageTU02302026-06-27
08800247359969UniSpace® TPLIF CageTU02402026-06-27
08800247359976UniSpace® TPLIF CageTU02502026-06-27
08800247359983UniSpace® TPLIF CageTU02602026-06-27
08800247359990UniSpace® TPLIF CageTU02702026-06-27
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
10889981065348MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065980MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065997MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981066000MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981066017MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981066024MarinerSeaspine Orthopedics CorporationMNH2016-09-02