FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446137764
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
540-00-003
Device description
DISCOVERY SCREW - HEXALOBULAR
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446137764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446137764001904461377641904461377640190446137764

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
07613327668896Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
00889024649637Nexel®Zimmer, Inc.JDC2024-08-16
07613327627404SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627411SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627428SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627435SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627244SOLARHowmedica Osteonics Corp.JDC2023-06-05
07613327627251SOLARHowmedica Osteonics Corp.JDC2023-06-05
20801902194644ARROWTELEFLEX INCORPORATEDJDC2022-11-08
00887868504051Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504075Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504099Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504174Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504181Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504198Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504228Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00846832012466Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
37613327590051Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
37613327590075Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
00889024639751NAZimmer, Inc.JDC2022-02-25
00889024639768NAZimmer, Inc.JDC2022-02-25
00889024639775NAZimmer, Inc.JDC2022-02-25
00889024639782NAZimmer, Inc.JDC2022-02-25
00889024639799NAZimmer, Inc.JDC2022-02-25
00889024639805NAZimmer, Inc.JDC2022-02-25
00889024466296Nexel®Zimmer, Inc.JDC2022-02-25
00887868543708Comprehensive® SRSBiomet Orthopedics, LLCJDC2021-11-21
00887868503375Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05
00887868503412Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05
00887868503436Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05