FDA.reportPublic FDA data

DISTRACTION, INTERNAL

Primary DI
00888118136619
Brand
DISTRACTION, INTERNAL
Company
KLS-Martin L.P.
Model
25-025-45-07
Device description
SPRING LIFTER, CRANIOXPAND
Published
2023-11-22
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
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118136619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118136619008881181366198881181366190888118136619

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

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
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B356KD905230American MedicalsAmerican MedicalsHTE2026-09-25
B356KD910090American MedicalsAmerican MedicalsHTE2026-09-25
00824846008477Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2026-09-19
00190776424350MillenniumAvalign Technologies, Inc.HTE2026-08-07
00198506091919ELMED INCORPORATEDELMED INCORPORATEDHTE2026-07-22
10705034579580N/AMedos International SàrlHTE2026-06-25
10705034579597N/AMedos International SàrlHTE2026-06-25
10705034579603N/AMedos International SàrlHTE2026-06-25
B8039702640ORTHOMEDORTHO-MED, INC.HTE2026-06-22
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
10840199507723SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507730SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507747ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507754ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507761ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507778ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507785ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507792ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507808ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507815ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507877ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507969ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511447ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511454ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526540ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526557ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199545558ElevatorKOROS U.S.A., INC.HTE2024-02-05
10840199527288ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527295ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527301ElevatorKOROS U.S.A., INC.HTE2024-01-31