FDA.reportPublic FDA data

Hex Driver

Primary DI
09348215109592
Brand
Hex Driver
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
02-039-90-7000
Published
2023-02-20
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

Product Codes#

Code, Name table
CodeName
HWRDriver, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215109592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215109592093482151095929348215109592

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215039295Liner Impactor112-152-0022018-10-09
09348215039301Liner Impactor112-152-3342018-10-09
09348215039318Liner Impactor112-152-1212018-10-09
09348215039325Liner Impactor112-152-0032018-10-09
09348215039332Ceramic Liner Inserter Impactor Head112-152-2102018-10-09
09348215039349Ceramic Liner Inserter Impactor Head112-152-2112018-10-09
09348215039356Ceramic Liner Inserter Impactor Head112-152-2122018-10-09
09348215039363Ceramic Liner Inserter Impactor Head112-152-2132018-10-09
09348215039387Ceramic Liner Impact Adaptor112-152-3052018-10-09
09348215039615Quick Release Head Impactor112-212-0172018-10-09
09348215039837Quick Release Stem Impactor112-212-0062018-10-09
09348215040758Head Impactor112-28-00112018-10-09
09348215040796Stem Impactor112-28-00292018-10-09
09348215040826Monoblock Head Impactor112-28-00382018-10-09
09348215040888Mjolnir112-28-00602018-10-12
09348215041250Femoral Impactor122-15-04642018-10-09
09348215041779Tibial Impactor122-15-04622018-10-09
09348215137427Swivel Stem Impactor112-32-03132025-10-10
09348215137434Swivel Stem Impactor - Long112-32-0314 2025-10-10
09348215152673Proximal Reamer Ø12111-552-4222025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500754Arthrex®ARTHREX, INC.HWR2026-03-13
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