FDA.reportPublic FDA data

Solitude Unipolar

Primary DI
00822409015016
Brand
Solitude Unipolar
Company
Ortho Development Corporation
Model
132-0059
Device description
59mm Unipolar
Published
2015-08-31
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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042973000SOLITUDE UNIPOLAR HEADOrtho Development Corp.2005-01-27KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409015016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409015016008224090150168224090150160822409015016

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head/stem prosthesis adaptorA sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter59Millimeter

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
00822409080311N/A228-00312026-05-16
00822409098880N/A853-10512026-05-16
00822409131297N/A853-00722026-05-16
00822409131525N/A267-55052026-05-16
00822409133253N/AC-1857-072026-05-16
00822409133260N/AC-1857-082026-05-16
00822409133277N/AC-1857-092026-05-16
00822409133284N/AC-1857-102026-05-16
00822409133291N/AC-1857-112026-05-16
00822409133307N/AC-1857-122026-05-16
00822409133314N/AC-1857-132026-05-16
00822409133321N/AC-1857-142026-05-16
00822409133338N/AC-1857-162026-05-16
00822409133345N/AC-1857-182026-05-16
00822409133352N/AC-1857-202026-05-16
00822409133369N/AC-1858-072026-05-16
00822409133376N/AC-1858-082026-05-16
00822409133383N/AC-1858-092026-05-16
00822409133390N/AC-1858-102026-05-16
00822409133406N/AC-1858-112026-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
07613153071273RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWL2015-09-24