FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446173427
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
804-07-065
Device description
AltiVate Anatomic, Humeral Protector, Large
Published
2022-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446173427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446173427001904461734271904461734270190446173427

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
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446776550DJO SURGICAL800-99-1632025-01-17
00190446776567DJO SURGICAL800-99-1642025-01-17
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446706304DJO SURGICAL800-99-1482022-10-18
00190446706311DJO SURGICAL800-99-1492022-10-18
00190446706328DJO SURGICAL800-99-1512022-10-18
00190446706335DJO SURGICAL800-99-1522022-10-18
00190446757665DJO SURGICAL800-99-1592022-08-17
00190446757672DJO SURGICAL800-99-1602022-08-17
00190446764274DJO SURGICAL800-99-1612022-08-17
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995303884V. MuellerSTERIS Deutschland GmbHHAO2026-09-25
04058749076042NAFehling Instruments GmbH & Co. KGHAO2026-09-21
00190776429126MillenniumAvalign Technologies, Inc.HAO2026-09-04
00190776423964MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776423995MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428068MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428075MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428082MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428099MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428105MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428112MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776420352MillenniumAvalign Technologies, Inc.HAO2026-08-25
00190776411558MillenniumAvalign Technologies, Inc.HAO2026-08-07
00190776407537MillenniumAvalign Technologies, Inc.HAO2026-08-03
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00810220800515Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00190776407377MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776407384MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19