FDA.reportPublic FDA data

3P Small-Mini Frag System

Primary DI
00840194495691
Brand
3P Small-Mini Frag System
Company
ORTHOPEDIATRICS CORP.
Model
01-3100-1005
Catalog number
01-3100-1005
Device description
Sharp Hook / Dental Pic
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840194495691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194495691008401944956918401944956910840194495691

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(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25
00841132125038General Instrument01-1003-300301-1003-30032016-09-25
00841132124277ACL01-1008-253001-1008-25302021-07-06
00841132122112OrthoPediatrics ACL Reconstruction System10-1008-106010-1008-10602015-09-18
00841132122129OrthoPediatrics ACL Reconstruction System10-1008-106510-1008-10652015-09-18
00841132122136OrthoPediatrics ACL Reconstruction System10-1008-107010-1008-10702015-09-18
00841132122143OrthoPediatrics ACL Reconstruction System10-1008-107510-1008-10752015-09-18
00841132122150OrthoPediatrics ACL Reconstruction System10-1008-108010-1008-10802015-09-18
00841132122167OrthoPediatrics ACL Reconstruction System10-1008-108510-1008-10852015-09-18
00841132122174OrthoPediatrics ACL Reconstruction System10-1008-109010-1008-10902015-09-18
00841132122181OrthoPediatrics ACL Reconstruction System10-1008-110010-1008-11002015-09-18
00841132122198OrthoPediatrics ACL Reconstruction System10-1008-406010-1008-40602015-09-18
00841132122204OrthoPediatrics ACL Reconstruction System10-1008-406510-1008-40652015-09-18
00841132122211OrthoPediatrics ACL Reconstruction System10-1008-407010-1008-40702015-09-18
00841132122228OrthoPediatrics ACL Reconstruction System10-1008-407510-1008-40752015-09-18
00841132122235OrthoPediatrics ACL Reconstruction System10-1008-408010-1008-40802015-09-18
00841132122242OrthoPediatrics ACL Reconstruction System10-1008-408510-1008-40852015-09-18
00841132126219General Instrument01-1008-000701-1008-00072016-09-25
00841132126226General Instrument01-1008-001001-1008-00102016-09-25

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