FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446266242
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
801-05-063
Device description
DJO EMPOWR KNEETM STEM TRIAL, 14MM X 40MM
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446266242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446266242001904462662421904462662420190446266242

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
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
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07
00888912078665DJO SURGICAL425-97-0082017-08-07
00888912078672DJO SURGICAL425-97-0092017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131782LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19