FDA.report

Acetabular Depth Gage

Primary DI
00819251024198
Brand
Acetabular Depth Gage
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
1215.00.000
Device description
Acetabular Depth Gage
Published
2019-11-04
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

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819251024198PrimaryGS10

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-use, sterileAn assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Storage And Handling

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

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
078416717
Device count
1
DM exempt
false
Premarket exempt
false
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

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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
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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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