FDA.reportPublic FDA data

Paragon

Primary DI
09340499023755
Brand
Paragon
Company
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Model
GM08001-210-08
Catalog number
GM08001-210-08
Device description
Paragon Stem Coxa Vara Sz 8 HA
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123782000PARAGON HIP SYSTEMGlobal Manufacturing Technology2013-03-14LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09340499023755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09340499023755093404990237559340499023755

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit hip femur prosthesis, one-pieceA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6128870100info@globalortho.com.au

Regulatory Flags#

DUNS number
752039982
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09340499024509ParagonGM08001-311-00GM08001-311-002016-09-09
09340499005195GRU TibiaGRU-0T-6.5-P-RGRU-0T-6.5-P-R2016-03-21
09340499005201GRU TibiaGRU-0T-7.5-P-RGRU-0T-7.5-P-R2016-03-23
09340499005218GRU TibiaGRU-0T-8.5-P-RGRU-0T-8.5-P-R2016-03-23
09340499005225GRU TibiaGRU-0T-9.5-P-RGRU-0T-9.5-P-R2016-03-23
09340499005232GRU TibiaGRU-1T-6.5-P-RGRU-1T-6.5-P-R2016-03-23
09340499005249GRU TibiaGRU-1T-7.5-P-RGRU-1T-7.5-P-R2016-03-23
09340499005256GRU TibiaGRU-1T-8.5-P-RGRU-1T-8.5-P-R2016-03-23
09340499005263GRU TibiaGRU-1T-9.5-P-RGRU-1T-9.5-P-R2016-03-23
09340499005270GRU TibiaGRU-2T-6.5-P-RGRU-2T-6.5-P-R2016-03-23
09340499005287GRU TibiaGRU-2T-7.5-P-RGRU-2T-7.5-P-R2016-03-23
09340499005294GRU TibiaGRU-2T-8.5-P-RGRU-2T-8.5-P-R2016-03-23
09340499005300GRU TibiaGRU-2T-9.5-P-RGRU-2T-9.5-P-R2016-03-23
09340499005317GRU TibiaGRU-3T-6.5-P-RGRU-3T-6.5-P-R2016-03-23
09340499005324GRU TibiaGRU-3T-7.5-P-RGRU-3T-7.5-P-R2016-03-23
09340499005331GRU TibiaGRU-3T-8.5-P-RGRU-3T-8.5-P-R2016-03-23
09340499005348GRU TibiaGRU-3T-9.5-P-RGRU-3T-9.5-P-R2016-03-23
09340499005355GRU TibiaGRU-4T-6.5-P-RGRU-4T-6.5-P-R2016-03-23
09340499005362GRU TibiaGRU-4T-7.5-P-RGRU-4T-7.5-P-R2016-03-23
09340499005379GRU TibiaGRU-4T-8.5-P-RGRU-4T-8.5-P-R2016-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01