FDA.report

Drill and Pin Set, Smooth

Primary DI
00819251025744
Brand
Drill and Pin Set, Smooth
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
2703.00.000
Device description
Drill and Pin Set, Smooth
Published
2021-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819251025744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819251025744008192510257448192510257440819251025744

GMDN Terms

TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00The Klassic Knee System should be stored in a clean, dry location at room temperature

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags

DUNS number
078416717
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05
00810094692742CR Femoral Trial, Grit BlastedSRI-10051.032026-02-05
00810094692759CR Femoral Trial, Grit BlastedSRI-10051.042026-02-05
00810094692766CR Femoral Trial, Grit BlastedSRI-10051.052026-02-05
00810094692773CR Femoral Trial, Grit BlastedSRI-10051.062026-02-05
00810094692780CR Femoral Trial, Grit BlastedSRI-10051.072026-02-05
00810094692674Klassic Knee Template, Tibial Baseplate, Revision2909.00.0002026-01-07
00810094692476Narrow Distal Femur Cut BlockSRI-100472025-08-27
00810094692544Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2417.00.2002025-07-28
00810094692339Acetabular Reamer AdapterSRI-100442025-06-26
00810094691790Klassic Knee Templates, Stem Extensions2806.00.0002025-05-14
00810094692322Spline Wrench, Closed2017.00.1002025-05-14
00810094692346Intramedullary Reamer, Revision2026.10.0002025-05-14
00810094692353Intramedullary Reamer, Revision2026.11.0002025-05-14
00810094692360Intramedullary Reamer, Revision2026.12.0002025-05-14
00810094692377Intramedullary Reamer, Revision2026.13.0002025-05-14
00810094692384Intramedullary Reamer, Revision2026.14.0002025-05-14
00810094692391Intramedullary Reamer, Revision2026.15.0002025-05-14
00810094692407Intramedullary Reamer, Revision2026.16.0002025-05-14

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