FDA.reportPublic FDA data

Escalade Acetabular System

Primary DI
00822409017102
Brand
Escalade Acetabular System
Company
Ortho Development Corporation
Model
170-0301
Device description
Apical Screw Plug
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
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
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
K103384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103384000ESCALADE ACETABULAR CUP SYSTEMOrtho Development2011-03-16LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409017102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409017102008224090171028224090171020822409017102

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis hole plugA sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.

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
07630542788314AMIStem-PMedacta International SALZO2026-06-08
07630542788321AMIStem-PMedacta International SALZO2026-06-08
07630542788338AMIStem-PMedacta International SALZO2026-06-08
07630542788345AMIStem-PMedacta International SALZO2026-06-08
07630542788352AMIStem-PMedacta International SALZO2026-06-08
07630542788369AMIStem-PMedacta International SALZO2026-06-08
07630542788376AMIStem-PMedacta International SALZO2026-06-08
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01