FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446286486
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-15-006
Device description
Driver, Swivel Joint, Bayonet
Published
2019-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00190446286486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446286486001904462864861904462864860190446286486

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
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
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00190446905998DJO SURGICAL800-05-2142026-03-03
00190446960515DJO SURGICALS-2019612026-02-17
00190446905950DJO SURGICAL800-05-2102026-02-11
00190446905974DJO SURGICAL800-05-2112026-02-11
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446906117DJO SURGICAL801-05-2122026-02-11
00190446924470DJO SURGICALS-2019282025-10-10
00190446946007DJO SURGICALS-2019562025-12-11
00190446893332DJO SURGICAL941-01-32B2025-12-04
00190446893349DJO SURGICAL941-01-36D2025-12-04
00190446893356DJO SURGICAL941-01-40F2025-12-04
00190446893363DJO SURGICAL941-01-44H2025-12-04
00190446893370DJO SURGICAL942-01-32B2025-12-04
00190446893387DJO SURGICAL942-01-36D2025-12-04
00190446893394DJO SURGICAL942-01-40F2025-12-04
00190446893400DJO SURGICAL942-01-44H2025-12-04

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