FDA.reportPublic FDA data

Paragon

Primary DI
09340499024509
Brand
Paragon
Company
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Model
GM08001-311-00
Catalog number
GM08001-311-00
Device description
Paragon Stem Inserter - Non-Threaded
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
09340499024509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09340499024509093404990245099340499024509

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
752039982
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09340499005386GRU TibiaGRU-4T-9.5-P-RGRU-4T-9.5-P-R2016-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24