FDA.reportPublic FDA data

NA

Primary DI
10886982192943
Brand
NA
Company
Synthes GmbH
Model
333.38
Catalog number
33338
Device description
OFFSET POINTED HOOK
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
10886982192943PrimaryGS10
H679333380SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219294310886982192943

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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00887482064061Symmetry BoneASPEN SURGICAL PRODUCTS, INC.KIK2024-08-07
B8039059150ORTHOMEDORTHO-MED, INC.KIK2024-07-03