FDA.reportPublic FDA data

Iconacy i-Hip

Primary DI
M914011030505600
Brand
Iconacy i-Hip
Company
Iconacy Orthopedic Implants LLC
Model
01-10305-056-00
Catalog number
01-10305-056-00
Device description
HXLP LINER, 32MM I.D. X 56MM O.D., 10 DEG., +3MM
Published
2015-11-13
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
K132572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132572000I-HIP TOTAL HIP SYSTEMIconacy Orthopedic Implants, LLC2014-03-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M914011030505600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter56Millimeter

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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