FDA.reportPublic FDA data

FORK

Primary DI
00888118120144
Brand
FORK
Company
KLS-Martin L.P.
Model
24-856-10-07
Device description
MICRO, SUTURE, CASPAR
Published
2018-11-22
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
00888118120144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118120144008881181201448881181201440888118120144

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118149244L1 THORACICCTM-24-015-84-042026-05-01
00888118149251L1 CMFCTM-55-911-83-042026-05-01
00888118149268L1 CMFCTM-55-911-84-042026-05-01
00888118149275L1 CMFCTM-55-911-85-042026-05-01
00888118149282L1 CMFCTM-55-911-86-042026-05-01
00888118149299L1 CMFCTM-55-911-87-042026-05-01
00888118149305L1 CMFCTM-55-911-88-042026-05-01
00888118149312L1 CMFCTM-55-911-89-042026-05-01
00888118149329L1 CMFCTM-55-911-90-042026-05-01
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24

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
00846468011208Cross-Fuse® II PEEK VBR/IBF SystemPioneer Surgical Technology, Inc.HXE2018-10-06
00888118064400FORKKLS-Martin L.P.HXE2018-09-26
24026704291865KMEDICTELEFLEX INCORPORATEDHXE2018-09-15
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