FDA.report

DJO SURGICAL

Primary DI
00888912167802
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
351-01-103
Device description
DJO EMPOWR KNEETM, FIN BP, NP, 3L
Published
2017-08-07
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
true

Related Records

Product Codes

CodeName
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications

CodeDeviceSpecialtyClass
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888912167802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912167802008889121678028889121678020888912167802

GMDN Terms

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

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
false
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 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

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00889024704749Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-08
00889024704862Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-08
00889024704541Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704565Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704589Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704657Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704664Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704718Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704763Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704824Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704848Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024658134Persona® Knee SystemZimmer, Inc.OIY2025-02-06
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00889024658417Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658455Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658493Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658516Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658523Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658561Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658622Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658653Persona® Knee SystemZimmer, Inc.OIY2025-02-06