FDA.reportPublic FDA data

FORK

Primary DI
00888118064400
Brand
FORK
Company
KLS-Martin L.P.
Model
38-885-18-07
Device description
REPOSITIONING, STEINHAUSER
Published
2018-09-26
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
00888118064400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118064400008881180644008881180644000888118064400

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00888118143037LEVEL ONE THORACIC, STERILE24-015-39-712024-10-08
00888118143044LEVEL ONE THORACIC, STERILE24-015-49-712024-10-08
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25

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
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