FDA.reportPublic FDA data

Actera hip system

Primary DI
00810933031404
Brand
Actera hip system
Company
Conformis, Inc.
Model
1080-673
Catalog number
1080-673
Device description
Actera Stem Digital Template
Published
2022-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810933031404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810933031404008109330314048109330314040810933031404

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic x-ray reference gridA device designed to superimpose a reference grid over an x-ray image during an orthopaedic procedure (e.g., surgery). It is a flat plate made of x-ray translucent material with a grid that is not translucent and therefore shows up on the x-ray image. It is only intended to assist alignment of anatomical structures (bones) and is not intended to take an accurate measurement of length (i.e., not an x-ray ruler). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808821883
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810933031114Cordera Hip System Offset Cup Impactor, Enztec1080-6461080-6462022-03-07
00810933031183Cordera Hip System Radel Liner Impactors 28mm1080-6551080-6552022-03-07
00810933031190Cordera Hip System Radel Liner Impactors 32mm1080-6561080-6562022-03-07
00810933031206Cordera Hip System Radel Liner Impactors 36mm1080-6571080-6572022-03-07
00810933031213Cordera Hip System Radel Liner Impactors 40mm1080-6581080-6582022-03-07
00810933031220Cordera Hip System T-handle Quick Connect1080-6591080-6592022-03-07
00810933031237Cordera Hip System OrthoGroup Cup Impactor1080-6601080-6602022-03-07
00850268007187iTotal® Impactor Head1080-5412016-10-24
00850268007194iTotal® Impactor Head1080-5352016-10-24
00850268007200iTotal® CR Tibial Tray Impactor Tip1080-5362016-10-24
00850268007217iTotal® PS Tibial Tray Impactor Tip1080-5422016-10-24
00850268007224iTotal® Poly Impactor Tip1080-5242016-10-24
M572HDL060C24S011iTotal® Hip Replacement SystemHDL060C24S01HDL060C24S2018-08-06
M572HDL060D24S011iTotal® Hip Replacement SystemHDL060D24S01HDL060D24S2018-07-30
M572HDL060D34S011iTotal® Hip Replacement SystemHDL060D34S01HDL060D34S2018-08-06
M572HDL060E24S011iTotal® Hip Replacement SystemHDL060E24S01HDL060E24S2018-08-06
M572HDL060E34S011iTotal® Hip Replacement SystemHDL060E34S01HDL060E34S2018-08-06
M572HDL060F24S011iTotal® Hip Replacement SystemHDL060F24S01HDL060F24S2018-08-06
M572HDL060F34S011iTotal® Hip Replacement SystemHDL060F34S01HDL060F34S2018-08-06
M572HDL060C10S011iTotal® Hip Replacement SystemHDL060C10S01HDL060C10S2018-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
09348215164577Longboard Trial Neck LOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164584Longboard Trial Neck SOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164591Longboard Trial Neck HOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
09348215082017Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082024Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082031Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082048Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082055Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215084998Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085018Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085025Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085032Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085049Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085056Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085063Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085070Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085087Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085094Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085100Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085117Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20