FDA.reportPublic FDA data

Alpine

Primary DI
00822409000401
Brand
Alpine
Company
Ortho Development Corporation
Model
700-1211
Device description
Alpine Cemented Stem 11 EXT
Published
2016-05-11
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
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153216000Alpine Cemented Hip SystemOrtho Development Corporation2016-02-18JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409000401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409000401008224090004018224090004010822409000401

GMDN Terms#

Term, Definition table
TermDefinition
Metal-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16
00822409082209N/A233-01462026-07-16
00822409082216N/A233-01472026-07-16
00822409082223N/A233-01482026-07-16
00822409082230N/A233-01492026-07-16
00822409082247N/A233-01502026-07-16
00822409082254N/A233-01512026-07-16
00822409082261N/A233-01522026-07-16
00822409082278N/A233-01532026-07-16
00822409082285N/A233-01542026-07-16
00822409082292N/A233-01552026-07-16
00822409082308N/A233-01562026-07-16
00822409082315N/A233-01572026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540035523OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.JDI2015-09-24
07613327016772UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016789UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016796UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016802UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016819UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016826UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016833UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016840UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016857UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016864UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016871UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016888UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016895UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016901UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016918UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016925UHRHowmedica Osteonics Corp.KWL2015-09-24