FDA.reportPublic FDA data

DISTRACTION, INTERNAL, STERILE

Primary DI
00888118114471
Brand
DISTRACTION, INTERNAL, STERILE
Company
KLS-Martin L.P.
Model
51-563-30-71
Device description
DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
Published
2018-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBJCranial Distraction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBJCranial Distraction SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118114471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118114471008881181144718881181144710888118114471

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorAn implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826499238
Device count
1
Lot or batch
true
Expiration date on label
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
00888118149367DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2025-09-24
00888118136589DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136596DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136626DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136633DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136640DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136657DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
10887587071817NASynthes GmbHPBJ2019-12-12
10887587071824NASynthes GmbHPBJ2019-12-12
10887587071831NASynthes GmbHPBJ2019-12-12
10887587071848NASynthes GmbHPBJ2019-12-12
10887587071855NASynthes GmbHPBJ2019-12-12
10887587071923NASynthes GmbHPBJ2019-12-12
10887587071930NASynthes GmbHPBJ2019-12-12
10887587071947NASynthes GmbHPBJ2019-12-12
10887587071954NASynthes GmbHPBJ2019-12-12
10887587072388NASynthes GmbHPBJ2019-12-12
10887587072395NASynthes GmbHPBJ2019-12-12
10887587072401NASynthes GmbHPBJ2019-12-12
10887587072418NASynthes GmbHPBJ2019-12-12
10887587072425NASynthes GmbHPBJ2019-12-12
10887587072517NASynthes GmbHPBJ2019-12-12
10887587072524NASynthes GmbHPBJ2019-12-12
10887587072531NASynthes GmbHPBJ2019-12-12
10887587072548NASynthes GmbHPBJ2019-12-12
10887587072555NASynthes GmbHPBJ2019-12-12
20887587071869NASynthes GmbHPBJ2019-12-12
20887587071876NASynthes GmbHPBJ2019-12-12
20887587071883NASynthes GmbHPBJ2019-12-12
20887587071890NASynthes GmbHPBJ2019-12-12