FDA.reportPublic FDA data

Cordera Hip System Femoral Stem Extractor Loop Adaptor

Primary DI
00810933031121
Brand
Cordera Hip System Femoral Stem Extractor Loop Adaptor
Company
Conformis, Inc.
Model
1080-649
Catalog number
1080-649
Device description
Femoral Stem Extractor Loop Adaptor
Published
2022-03-07
Public version status
New
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
00810933031121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810933031121008109330311218109330311210810933031121

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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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