FDA.reportPublic FDA data

Conformis Hip System

Primary DI
00850268007590
Brand
Conformis Hip System
Company
Conformis, Inc.
Model
1080-565
Device description
TRIAL HEAD, 28MM +7
Published
2020-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850268007590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850268007590008502680075908502680075900850268007590

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter28Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags#

DUNS number
808821883
Device count
1
DM exempt
false
Premarket exempt
true
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
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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Primary DI, Brand, Company table
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