FDA.reportPublic FDA data

NA

Primary DI
10885862057952
Brand
NA
Company
Exactech, Inc.
Model
213-02-03
Catalog number
213-02-03
Device description
ROTATION WEDGE, LPI, 3°
Published
2022-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032606000
K033883000
K093360000
K111400000
K121307000
K123687000
K140302000
K935773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032606000OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTSExactech, Inc.2003-09-23JWH
K033883000OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIExactech, Inc.2004-02-13JWH
K093360000OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010-01-11JWH
K111400000OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTExactech, Inc.2011-07-28JWH
K121307000OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZExactech, Inc.2012-05-31JWH
K123687000OPTETRAK LOGIC POROUS FEMORAL COMPONENTExactech, Inc.2013-03-20JWH
K140302000OPTETRAK LOGIC POROUS FEMORAL COMPONENTSExactech, Inc.2014-07-30MBH
K935773000EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENTExactech, Inc.1994-12-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862057952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586205795210885862057952

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862094780OpteCure650-00-01650-00-012016-07-17
10885862094797OpteCure650-00-02650-00-022016-07-17
10885862094803OpteCure650-00-05650-00-052016-06-17
10885862094810OpteCure650-00-10650-00-102016-07-17
10885862094827Optecure650-00-20650-00-202016-09-19
10885862094841OpteCure+CCC652-00-01652-00-012016-07-17
10885862094858OpteCure+CCC652-00-02652-00-022016-07-17
10885862094865OpteCure+CCC652-00-05652-00-052016-07-17
10885862094872OpteCure+CCC652-00-10652-00-102016-07-17
10885862094889OpteCure+CCC652-00-20652-00-202016-07-17
10885862095039Ossigen660-00-20660-00-202016-07-17
10885862252593Entice +CCC692-00-01692-00-012016-07-17
10885862252609Entice +CCC692-00-02692-00-022016-07-17
10885862252616Entice +CCC692-00-05692-00-052016-07-17
10885862252623Entice +CCC692-00-10692-00-102016-07-17
10885862252630Entice +CCC692-00-20692-00-202016-07-17
10885862252845Entice690-00-01690-00-012016-07-17
10885862252852Entice690-00-02690-00-022016-07-17
10885862252869Entice690-00-05690-00-052016-07-17
10885862252876Entice690-00-10690-00-102016-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
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05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
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05056139247798Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248016Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248023Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248313Unity Total Knee SystemCORIN LTDJWH2026-10-19