FDA.report

DJO SURGICAL

Primary DI
00190446174141
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
804-07-254
Device description
AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 54
Published
2022-08-09
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

Related Records

Product Codes

CodeName
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Product Code Classifications

CodeDeviceSpecialtyClass
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446174141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446174141001904461741411904461741410190446174141

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
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 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 DIBrandCompanyProduct codePublished
00887868580710Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
00887868580758Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
04026575439751LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-12
04026575534746LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-11
04026575439546LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439553LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439560LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439577LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533510LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533527LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533534LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533541LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533558LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533565LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533572LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533589LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533596LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533602LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533619LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533626LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533633LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533640LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533411LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533428LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533442LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533657LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533718LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533725LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533732LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533749LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22