FDA.reportPublic FDA data

DISTRACTION, INTERNAL

Primary DI
00888118054166
Brand
DISTRACTION, INTERNAL
Company
KLS-Martin L.P.
Model
26-702-15-09
Device description
DIST, FINGER, ZURICH 1, FRONT DRV, RIGID ACT ARM, 2.0-2.3 MM SCREW, TI-6AL-4V
Published
2016-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JECCOMPONENT, TRACTION, INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118054166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118054166008881180541668881180541660888118054166

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681330MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680456MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680470MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680487MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680494MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680500MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680517MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680524MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680531MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680548MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680555MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680562MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680579MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29