FDA.reportPublic FDA data

Iconacy i-Hip

Primary DI
M914011090103000
Brand
Iconacy i-Hip
Company
Iconacy Orthopedic Implants LLC
Model
01-10901-030-00
Catalog number
01-10901-030-00
Device description
BONE SCREW, 6.5MM DIAMETER, 30MM LENGTH
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
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
M914011090103000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterile"A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression across bone fragments."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter

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
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
M914011010205000Iconacy i-Hip01-10102-050-0001-10102-050-002015-10-30

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