FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446303961
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-44-28B
Device description
Trial Liner, EMPOWR Acetabular, +4mm, 28B
Published
2020-04-30
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
FZXGuide, surgical, instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190057000DJO Acetabular SystemEncore Medical L.P.2019-06-07LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446303961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446303961001904463039611904463039610190446303961

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
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
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24
09421038412275KA Femoral Alignment Guide – IM GuideENZTEC LIMITEDFZX2026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide ConnectorENZTEC LIMITEDFZX2026-06-24
03700879518701NANOVASTEPFZX2026-06-23
03700879518718NANOVASTEPFZX2026-06-23
03700879518725NANOVASTEPFZX2026-06-23
03700879518732NANOVASTEPFZX2026-06-23
08800089483440Surgical InstrumentJeil Medical CorporationFZX2026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2026-06-10
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944960183P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962613P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944972063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
00889024701526Identity® Shoulder SystemZimmer, Inc.FZX2026-06-10
00889795154538Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154545Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154613Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02