FDA.reportPublic FDA data

NA

Primary DI
10885862059291
Brand
NA
Company
Exactech, Inc.
Model
213-53-21
Catalog number
213-53-21
Device description
FEMORAL PS NOTCH GUIDE, LPI NMC, SIZE 1
Published
2022-08-18
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
K954208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954208000OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLYExactech, Inc.1996-02-26JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862059291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586205929110885862059291

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
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05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
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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
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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