FDA.reportPublic FDA data

Paragon

Primary DI
09340499024516
Brand
Paragon
Company
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Model
GM08001-323-00
Catalog number
GM08001-323-00
Device description
Paragon Slap Hammer Adaptor
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
09340499024516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09340499024516093404990245169340499024516

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). 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
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
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15