FDA.reportPublic FDA data

SFS

Primary DI
18257200053759
Brand
SFS
Company
ORTHOFIX INC.
Model
55-1045
Device description
LOCKING PLIERS
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTCPLIERS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200053759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720005375918257200053759

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200068166PILLAR XL72-19092019-03-19
18257200081387CONSTRUX - PEEK VBR450217-000148-00102020-02-03
18257200131969PEMF - PHYSIO-STIM655302-000153022020-01-16
18257200131976PEMF - PHYSIO-STIM655303-000153032020-01-16
18257200131983PEMF - PHYSIO-STIM655313-000153132020-01-16
18257200131990PEMF - PHYSIO-STIM655314-00015314L2020-01-16
18257200132003PEMF - PHYSIO-STIM655314-01015314R2020-01-16
18257200132010PEMF - PHYSIO-STIM655315-000153152020-01-16
18257200022151FORZA87-1209SP2019-09-24
18257200022168FORZA87-1210SP2019-09-24
18257200022175FORZA87-1211SP2019-09-24
18257200022182FORZA87-1212SP2019-09-24
18257200022199FORZA87-1213SP2019-09-24
18257200022205FORZA87-1214SP2019-09-24
18257200022212FORZA87-1215SP2019-09-24
18257200022229FORZA87-1216SP2019-09-24
18257200022236FORZA87-1308SP2019-09-24
18257200022243FORZA87-1309SP2019-09-24
18257200022250FORZA87-1310SP2019-09-24
18257200022267FORZA87-1311SP2019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB71190TBS BASICSACME ENTERPRISE.HTC2026-05-22
D9281301290SLOTTED SPONGE FORCEPS, 15CMW.H. Holden, Inc.HTC2026-01-05
03662663217651Posterior Cervical Removal InstrumentsHighridge Medical, LLCHTC2025-12-17
00840314270207gSourceGSOURCE LLCHTC2025-11-17
00840314270214gSourceGSOURCE LLCHTC2025-11-17
00885556908860EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911570EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911587EVOSSmith & Nephew, Inc.HTC2025-11-11
00841336106109Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106116Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106123Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106130Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
08033390289061ArTTLIMACORPORATE SPAHTC2025-09-25
B356KE334280American MedicalsAmerican MedicalsHTC2025-09-15
B356KJ522130American MedicalsAmerican MedicalsHTC2025-09-12
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00841435111165TecometTECOMET INC.HTC2025-08-27
00841435111172TecometTECOMET INC.HTC2025-08-27
00841435111189TecometTECOMET INC.HTC2025-08-27
00841435111202TecometTECOMET INC.HTC2025-08-27
00841435118263TecometTECOMET INC.HTC2025-08-27
00841435118287TecometTECOMET INC.HTC2025-08-27
00841435118317TecometTECOMET INC.HTC2025-08-27