FDA.reportPublic FDA data

Kosmo Femoral Hip System

Primary DI
00843575110879
Brand
Kosmo Femoral Hip System
Company
B-ONE ORTHO, CORP.
Model
8819000021
Catalog number
8819000021
Device description
SCALLOP IMPACTOR
Published
2021-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843575110879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575110879008435751108798435751108790843575110879

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081315444
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843575106445MOBIO™ Total Knee System882133320988213332092026-05-29
00843575106452MOBIO™ Total Knee System882133321088213332102026-05-29
00843575106469MOBIO™ Total Knee System882133321188213332112026-05-29
00843575106476MOBIO™ Total Knee System882133321388213332132026-05-29
00843575106483MOBIO™ Total Knee System882133321688213332162026-05-29
00843575106490MOBIO™ Total Knee System882133321988213332192026-05-29
00843575106506MOBIO™ Total Knee System882133322288213332222026-05-29
00843575106513MOBIO™ Total Knee System882133322588213332252026-05-29
00843575106520MOBIO™ Total Knee System882134320988213432092026-05-29
00843575106537MOBIO™ Total Knee System882134321088213432102026-05-29
00843575106544MOBIO™ Total Knee System882134321188213432112026-05-29
00843575106551MOBIO™ Total Knee System882134321388213432132026-05-29
00843575106568MOBIO™ Total Knee System882134321688213432162026-05-29
00843575106575MOBIO™ Total Knee System882134321988213432192026-05-29
00843575106582MOBIO™ Total Knee System882134322288213432222026-05-29
00843575106599MOBIO™ Total Knee System882134322588213432252026-05-29
00843575107619MOBIO™ Total Knee System882930200988293020092026-05-29
00843575107626MOBIO™ Total Knee System882930201088293020102026-05-29
00843575107633MOBIO™ Total Knee System882930201188293020112026-05-29
00843575107640MOBIO™ Total Knee System882930201388293020132026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780224815Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224822Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224839Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224846Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224853Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224860Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224877Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224884Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224891Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780278283Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09
10381780278290Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09