FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327563504
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
7000-5526
Catalog number
7000-5526
Device description
Offset Broach Handle-Lever
Published
2022-01-18
Public version status
New
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
07613327563504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327563504076133275635047613327563504

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

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