FDA.reportPublic FDA data

GRIPTION

Primary DI
10603295381402
Brand
GRIPTION
Company
DEPUY (IRELAND)
Model
1217-45-800
Catalog number
121745800
Device description
GRIPTION TF SCREW 5.5mm x 45mm
Published
2015-09-24
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123924000DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWSDepuy Orthopaedics2013-03-01LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295381402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329538140210603295381402

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., surgical steel).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09