FDA.reportPublic FDA data

Omnifit

Primary DI
07613327013603
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
1058-0007
Catalog number
1058-0007
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
07613327013603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327013603076133270136037613327013603

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
07613327128420Simplex6197-9-0016197-9-0012017-06-19
07613327128437Simplex6188-1-0016188-1-0012015-09-24
07613327128444Simplex6191-1-0016191-1-0012015-09-24
07613327128451Simplex6192-1-0016192-1-0012017-06-19
07613327181531INSTRUMENT0901-1-0000901-1-0002016-09-24
07613327020786Secur-Fit6054-0509S6054-0509S2015-09-24
07613327020793Secur-Fit6054-0511S6054-0511S2015-09-24
07613327020809Secur-Fit6054-0610S6054-0610S2015-09-24
07613327020816Secur-Fit6054-0612S6054-0612S2015-09-24
07613327020823Secur-Fit6054-0812S6054-0812S2015-09-24
07613327020830Secur-Fit6054-0713S6054-0713S2015-09-24
07613327020847Secur-Fit6054-0711S6054-0711S2015-09-24
07613327020854Secur-Fit6054-0814S6054-0814S2015-09-24
07613327020861Secur-Fit6054-0913S6054-0913S2015-09-24
07613327020878Secur-Fit6054-1014S6054-1014S2015-09-24
07613327020885Secur-Fit6054-1016S6054-1016S2015-09-24
07613327020892Secur-Fit6054-0915S6054-0915S2015-09-24
07613327020908Secur-Fit6054-1115S6054-1115S2015-09-24
07613327020915Secur-Fit6054-1117S6054-1117S2015-09-24
07613327020922Secur-Fit6054-1216S6054-1216S2015-09-24

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
07613327013580OmnifitHowmedica Osteonics Corp.LTO2015-09-24
07613327013597OmnifitHowmedica 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