FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446181156
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-51-448
Device description
FMP ACETABULAR TRIAL LINER, NON-HOODED, 28MM/44MM-MP3
Published
2018-02-02
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
K172651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172651000FMP Extended LinersEncore Medical L.P.2017-12-13OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446181156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446181156001904461811561904461811560190446181156

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

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
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
18257200131198Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131204Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131235Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131334Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200163625PILLAR SA TiOrthofix US LLCFZX2026-07-17
00190446972020Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
00190446972037Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
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