FDA.reportPublic FDA data

Iconacy i-Hip

Primary DI
M914011000100802
Brand
Iconacy i-Hip
Company
Iconacy Orthopedic Implants LLC
Model
01-10001-008-02
Catalog number
01-10001-008-02
Device description
LATERAL FEMORAL STEM, SIZE 8
Published
2015-10-16
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
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121034000IOI TOTAL HIPIconacy Orthopedic Implants, LLC2012-09-04LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M914011000100802PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width8Millimeter

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

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