FDA.reportPublic FDA data

NA

Primary DI
10886982201416
Brand
NA
Company
Synthes GmbH
Model
398.52
Catalog number
39852
Device description
MEDIUM BONE HOOK 230MM
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIKHOOK, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIKHook, BoneGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982201416PrimaryGS10
H679398520SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698220141610886982201416

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427290MillenniumAvalign Technologies, Inc.KIK2026-08-21
008401944956913P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIK2026-06-10
03662663083560ActivLHighridge Medical, LLCKIK2026-02-03
00885556911990EVOSSmith & Nephew, Inc.KIK2025-11-12
00885556912003EVOSSmith & Nephew, Inc.KIK2025-11-12
00885556912010EVOSSmith & Nephew, Inc.KIK2025-11-12
00847538007930Bone Hook - SmallSYMMETRY MEDICAL INC.KIK2025-10-20
G767CBW1010Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
G767JSH1040Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
G767S1040110Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
00194613104870MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-08-01
00194613115746MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-08-01
00190776404697MillenniumAvalign Technologies, Inc.KIK2025-07-10
00190776401832MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776401849MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776401856MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776394912MillenniumAvalign Technologies, Inc.KIK2025-05-08
00190776394707MillenniumAvalign Technologies, Inc.KIK2025-05-07
08403207009739Anmuth Medical InternationalAnmuth Medical International, LLCKIK2025-03-24
00194613086817MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
00194613103774MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
00194613111267MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
G586N882131B0Novo SurgicalNOVO SURGICAL, INC.KIK2024-10-25
00887868582318Affixus®Zimmer, Inc.KIK2024-10-17
00889795137111Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00889795137234Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00889795141248Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00190776385514MillenniumAvalign Technologies, Inc.KIK2024-08-29
00190776384760MillenniumAvalign Technologies, Inc.KIK2024-08-22
00887482064054Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KIK2024-08-07