FDA.reportPublic FDA data

Omnifit

Primary DI
07613327013580
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
1058-0005
Catalog number
1058-0005
Device description
Proximal Cement Spacer
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
LTOSPACER, CEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTOSpacer, CementOrthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895378000PROXIMAL CEMENT SPACEROsteonics Reconstructive Products Div.1989-11-22JDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327013580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327013580076133270135807613327013580

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540007896Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007902Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007919Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007926Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007933Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007940Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
04546540007957Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
07613153768371Bone PlugHowmedica Osteonics Corp.LTO2015-09-24
07613327013597OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013603OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013610OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013627OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013634OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013641OmnifitHowmedica Osteonics Corp.LTO2015-09-24