FDA.report

PHOENIX SFS

Primary DI
18257200028313
Brand
PHOENIX SFS
Company
ORTHOFIX INC.
Model
20-0214
Device description
ROD HOLDER-INSERTER
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

Related Records

Contact Domains

Product Codes

CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications

CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18257200028313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1825720002831318257200028313

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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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 DIBrandCompanyProduct codePublished
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00888867500761Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500778Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500839Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500877Arthrex®ARTHREX, INC.HWR2026-03-13
10705034579085N/AMedos International SàrlHWR2026-03-05
G079C5080000250MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2026-01-30
0088902470557940mm Head PusherZimmer, Inc.HWR2026-01-16
04026575315727MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHWR2026-01-06
00840180543535General InstrumentsALPHATEC SPINE, INC.HWR2025-12-31
04719886910766U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
04719886910902USTAR II Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
10705034643564TRIALTISMedos International SàrlHWR2025-11-13
07640332476307SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
07640332476314SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
00190376662213IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662237IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662244IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662251IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662268IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662275IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662282IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662299IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662305IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662312IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00889797111331Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HWR2025-08-26
G079AOL1380Advantage -LUMBAR InterbodyIntelivation, LLCHWR2025-08-07
00763000879594ENDOSKELETON® TCSMEDTRONIC SOFAMOR DANEK, INC.HWR2025-07-25
10705034589725TRIALTIS Spine SystemDEPUY SPINE, LLCHWR2025-07-17
04719886909593U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-07-14