FDA.reportPublic FDA data

N/A

Primary DI
B58208012120
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
0801212
Catalog number
0801212
Device description
IMPACTOR
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B58208012120PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags#

DUNS number
107043630
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B58208011750N/A080117508011752020-09-24
B58208011770N/A080117708011772020-09-24
B58208011810N/A080118108011812020-09-24
B58208012000N/A080120008012002020-09-24
B58208012050N/A080120508012052020-09-24
B58208012130N/A080121308012132020-09-24
B58208012160N/A080121608012162020-09-24
B582081899N/A0818990818992020-09-24
B58208349610N/A08349610083496102020-09-24
B5820834962N/A083496208349622020-09-24
B5820834963N/A083496308349632020-09-24
B5820834964N/A083496408349642020-09-24
B5820834965N/A083496508349652020-09-24
B5820834966N/A083496608349662020-09-24
B5820834968N/A083496808349682020-09-24
B582080140720N/A08014072080140722020-09-24
B582080141040N/A08014104080141042020-09-24
B582080BYRDCURETTE20N/A080BYRD CURETTE2080BYRD CURETTE22020-09-24
B582080BYRDCURETTE200N/A080BYRD CURETTE2/0080BYRD CURETTE202020-09-24
B582105717470N/A10571747105717472020-09-24

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
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
10381780278641Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09
10381780278863Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.HWA2018-03-09