FDA.report

ITOTAL OVAL PATELLA TRIAL 38MM

Primary DI
00810933030438
Brand
ITOTAL OVAL PATELLA TRIAL 38MM
Company
Conformis, Inc.
Model
1080-204
Published
2019-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OOGKnee Arthroplasty Implantation System

Product Code Classifications

CodeDeviceSpecialtyClass
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810933030438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810933030438008109330304388109330304380810933030438

GMDN Terms

TermDefinition
Patella prosthesis trialA copy of a final patella prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis, and to check that patellar ligament balancing is correct. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Outer Diameter38Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags

DUNS number
808821883
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

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M572TCR000D00F021Identity Imprint CR Knee Replacement SystemTCR-000-D00F1TCR-000-D00F2024-06-26
M572TCR000D00T021Identity Imprint CR Knee Replacement SystemTCR-000-D00T1TCR-000-D00T2024-06-26
M572TPS000D00F021Identity Imprint PS Knee Replacement SystemTPS-000-D00F1TPS-000-D00F2024-06-26
M572TCR302T07S011Identity Imprint Porous CR TCR-302-T07S-01TCR-302-T07S2024-01-24
00810933031817Calcar Planer Adapter Drop-in1080-7001080-7002023-12-05
M572POV0123208011Identity Imprint Porous CR POV-012-3208-01POV-012-32082023-09-08
M572POV0123509011Identity Imprint Porous CR POV-012-3509-01POV-012-35092023-09-08
M572POV0123809011Identity Imprint Porous CR POV-012-3809-01POV-012-38092023-09-08
M572POV0124110011Identity Imprint Porous CR POV-012-4110-01POV-012-41102023-09-08
M572POV0124411011Identity Imprint Porous CR POV-012-4411-01POV-012-44112023-09-08
M572TCR102F01S011Identity Imprint Porous CRTCR-102-F01S-01TCR-102-F01S2023-09-08
M572TCR102F02N011Identity Imprint Porous CR TCR-102-F02N-01TCR-102-F02N2023-09-08
M572TCR102F02S011Identity Imprint Porous CR TCR-102-F02S-01TCR-102-F02S2023-09-08
M572TCR102F03N011Identity Imprint Porous CR TCR-102-F03N-01TCR-102-F03N2023-09-08
M572TCR102F03S011Identity Imprint Porous CR TCR-102-F03S-01TCR-102-F03S2023-09-08
M572TCR102F04N011Identity Imprint Porous CR TCR-102-F04N-01TCR-102-F04N2023-09-08
M572TCR102F04S011Identity Imprint Porous CR TCR-102-F04S-01TCR-102-F04S2023-09-08
M572TCR102F05N011Identity Imprint Porous CR TCR-102-F05N-01TCR-102-F05N2023-09-08
M572TCR102F05S011Identity Imprint Porous CR TCR-102-F05S-01TCR-102-F05S2023-09-08
M572TCR102F06N011Identity Imprint Porous CR TCR-102-F06N-01TCR-102-F06N2023-09-08

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