FDA.reportPublic FDA data

Affixus®

Primary DI
00887868582318
Brand
Affixus®
Company
Zimmer, Inc.
Model
211302003
Catalog number
211302003
Published
2024-10-17
Public version status
New
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
00887868582318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868582318008878685823188878685823180887868582318

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)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
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
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

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
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
B8039059250ORTHOMEDORTHO-MED, INC.KIK2024-07-03