FDA.reportPublic FDA data

NA

Primary DI
10885862059109
Brand
NA
Company
Exactech, Inc.
Model
213-52-21
Catalog number
213-52-21
Device description
COUPLER, SPIKED, LPI, TIBIAL RESECTOR
Published
2022-07-28
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
K011976000
K071738000
K093360000
K101981000
K110547000
K132161000
K932776000
K933610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011976000OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)Exactech, Inc.2001-07-16JWH
K071738000EXACTECH OPTETRAK PROXIMAL TIBIAL SPACERExactech, Inc.2007-08-15JWH
K093360000OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010-01-11JWH
K101981000OPTETRAK LOGIC COMBINATION TIBIAL TRAYExactech, Inc.2010-08-02JWH
K110547000OPTERTRAK LOGIC PSC TIBIAL INSERTExactech Sarasota2011-04-14JWH
K132161000OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSExactech, Inc.2013-10-11JWH
K932776000CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSExactech, Inc.1994-10-20JWH
K933610000EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSExactech, Inc.1995-01-17JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862059109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586205910910885862059109

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

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
05056139247712Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDJWH2026-10-19
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