FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704291865
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015702
Catalog number
KM69790
Published
2018-09-15
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
HXEFORK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXEForkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704291861Direct MarkingGS10
24026704291865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704291861040267042918614026704291861
2402670429186524026704291865

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16.5Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889797111317Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXE2025-08-26
00191083033204Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-18
00191083033211Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-12
00191083033198Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-03-31
00842962170779HNM MedicalHNM STAINLESS, LLC.HXE2024-03-07
00190776337773MillenniumAvalign Technologies, Inc.HXE2023-06-23
00191083033181Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2023-03-31
04047844111765COSYSIGNUS Medizintechnik GmbHHXE2023-03-15
00191083033174Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2022-03-31
B922F00400270ACURA Stabilization System - Rod Lever/ Reduction ForkINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXE2022-03-21
00840192715241FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
00840192715548FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
08800037544964ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-11-14
04038653164134AESCULAPAesculap AGHXE2020-07-06
04046963780128ACTIV CAesculap AGHXE2020-04-24
04046963783143ACTIV CAesculap AGHXE2020-04-24
04038653403943NOVOCARTAesculap AGHXE2020-04-23
08800037523969ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-01-12
08800015999939ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2019-07-29
00889024577527ExtremitiesZimmer, Inc.HXE2019-07-01
00840019925853PSS SystemPRECISION SPINE, INC.HXE2019-03-27
07640139349149OTELO INSTRUMENTATIONSpineArt SAHXE2019-02-01
00888118120144FORKKLS-Martin L.P.HXE2018-11-22
00846468011208Cross-Fuse® II PEEK VBR/IBF SystemPioneer Surgical Technology, Inc.HXE2018-10-06
00888118064400FORKKLS-Martin L.P.HXE2018-09-26
08800015951982Optima™ Spinal SystemCG MedTech Co.,Ltd.HXE2017-11-02
08800015959438OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
08800015959414OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
M697C06700430Certex Spinal Fixation SystemXtant Medical Holdings, Inc.HXE2017-04-01
10889981080419MalibuSeaspine Orthopedics CorporationHXE2016-05-02