FDA.report

Optetrak

Primary DI
10885862048103
Brand
Optetrak
Company
Exactech, Inc.
Model
204-16-11
Catalog number
204-16-11
Published
2015-10-30
Public version status
Update
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K933494000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K933494000EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEMExactech, Inc.1995-03-10JWH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862048103PrimaryGS10

GMDN Terms

TermDefinition
Uncoated knee tibia prosthesis, polyethyleneAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes

TypeValueUnit
Height9Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

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10885862648105Equinoxe313-05-02313-05-022026-03-19
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10885862648136Equinoxe313-07-02313-07-022026-03-19
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10885862648150Equinoxe313-07-05313-07-052026-03-19
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10885862648174Equinoxe313-07-10313-07-102026-03-19
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10885862648266Equinoxe313-25-41313-25-412026-03-19
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10885862648280Equinoxe313-25-47313-25-472026-03-19

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00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
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00843575127327MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127334MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127341MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
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