FDA.reportPublic FDA data

GRU Tibia

Primary DI
09340499005201
Brand
GRU Tibia
Company
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Model
GRU-0T-7.5-P-R
Catalog number
GRU-0T-7.5-P-R
Device description
GRU Tibia Size 0 7.5mm
Published
2016-03-23
Public version status
Update
Distribution status
Not 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
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051721000GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEMGlobal Orthopaedic Technology, USA, Inc.2005-10-26HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09340499005201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09340499005201093404990052019340499005201

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee tibia prosthesis, polyethyleneA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, and its implantation is intended to be performed with bone cement.

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
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
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422650SignatureMaterialise NVHRY2026-09-24
E31442422651SignatureMaterialise NVHRY2026-09-24
E31442422652SignatureMaterialise NVHRY2026-09-24
E31442422653SignatureMaterialise NVHRY2026-09-24
E31442422660SignatureMaterialise NVHRY2026-09-24
E31442422661SignatureMaterialise NVHRY2026-09-24
E31442422662SignatureMaterialise NVHRY2026-09-24
E31442422663SignatureMaterialise NVHRY2026-09-24
E31442422670SignatureMaterialise NVHRY2026-09-24
E31442422671SignatureMaterialise NVHRY2026-09-24
E31442422672SignatureMaterialise NVHRY2026-09-24
E31442422673SignatureMaterialise NVHRY2026-09-24
00192629082854EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18