FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327417289
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-H2148HF00
Catalog number
I-H2148HF00
Device description
SPECIALTY SECUR-FIT ADVANCED BROACH HANDLE
Published
2018-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWLSET, HOLLOW MILL
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWLSet, Hollow MillOrthopedic1
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327417289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327417289076133274172897613327417289

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true
Sterilization required before use
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
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
10603295518761SMARTSETDEPUY (IRELAND)KWL2026-09-10
10603295518761SMARTSETDEPUY (IRELAND)KWY2026-09-10
00190446153917DJO SURGICALEncore Medical, L.P.LWJ2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.LZO2017-03-30
00190446153917DJO SURGICALEncore Medical, L.P.KWZ2017-03-30
00190446153924DJO SURGICALEncore Medical, L.P.LWJ2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.KWZ2017-03-07
00190446153924DJO SURGICALEncore Medical, L.P.LZO2017-03-07