FDA.report

DJO SURGICAL

Primary DI
00190446137641
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
540-13-115
Device description
DISC ULNA 3X115MM LT W/BRNG C
Published
2017-05-01
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

Related Records

Product Codes

CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446137641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446137641001904461376411904461376410190446137641

GMDN Terms

TermDefinition
Metal-backed elbow ulna prosthesisA sterile implantable device designed to replace the proximal ulna as part of an elbow joint replacement. The device is typically comprised of metal-backed polyethylene (PE) and its stem is usually coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods

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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00190446893417DJO SURGICAL943-01-32B2025-12-04
00190446893424DJO SURGICAL943-01-36D2025-12-04
00190446893431DJO SURGICAL943-01-40F2025-12-04
00190446893448DJO SURGICAL943-01-44H2025-12-04

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00846832012466Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
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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
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00889024639799NAZimmer, Inc.JDC2022-02-25
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00887868543708Comprehensive® SRSBiomet Orthopedics, LLCJDC2021-11-21
00887868503375Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05
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00887868503436Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05