FDA.reportPublic FDA data

Iconacy i-Hip

Primary DI
M914011010100000
Brand
Iconacy i-Hip
Company
Iconacy Orthopedic Implants LLC
Model
01-10101-000-00
Catalog number
01-10101-000-00
Device description
I-HIP APEX HOLE PLUG
Published
2015-11-27
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131279000ICONACY I-HIP SYSTEMIconacy Orthopedic Implants, LLC2013-08-09LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M914011010100000PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
574-269-4266rhori@iconacy.com

Regulatory Flags#

DUNS number
032218374
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
M914011090101500Iconacy i-Hip01-10901-015-0001-10901-015-002015-11-27
M914011090102000Iconacy i-Hip01-10901-020-0001-10901-020-002015-11-27
M914011090102500Iconacy i-Hip01-10901-025-0001-10901-025-002015-11-27
M914011090103000Iconacy i-Hip01-10901-030-0001-10901-030-002015-11-27
M914011090103500Iconacy i-Hip01-10901-035-0001-10901-035-002015-11-27
M914011090104000Iconacy i-Hip01-10901-040-0001-10901-040-002015-11-27
M914011090104500Iconacy i-Hip01-10901-045-0001-10901-045-002015-11-27
M914011090105000Iconacy i-Hip01-10901-050-0001-10901-050-002015-11-27
M914011010104600Iconacy i-Hip01-10101-046-0001-10101-046-002015-10-16
M914011010104800Iconacy i-Hip01-10101-048-0001-10101-048-002015-10-16
M914011010105000Iconacy i-Hip01-10101-050-0001-10101-050-002015-10-16
M914011010105200Iconacy i-Hip01-10101-052-0001-10101-052-002015-10-16
M914011010105400Iconacy i-Hip01-10101-054-0001-10101-054-002015-10-16
M914011010105600Iconacy i-Hip01-10101-056-0001-10101-056-002015-10-16
M914011010105800Iconacy i_hip01-10101-058-0001-10101-058-002015-10-16
M914011010106000Iconacy i-Hip01-10101-060-0001-10101-060-002015-10-16
M914011010106200Iconacy i-Hip01-10101-062-0001-10101-062-002015-10-16
M914011010106400Iconacy i-Hip01-10101-064-0001-10101-064-002015-10-16
M914011010204600Iconacy i-Hip01-10102-046-0001-10102-046-002015-10-30
M914011010204800Iconacy i-Hip01-10102--048-0001-10102-048-002015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01