DEVICE: ACTERA (M572HES03410CH011)
Device Identifier (DI) Information
ACTERA
HES-034-10CH-01
In Commercial Distribution
HES-034-10CH
Conformis, Inc.
HES-034-10CH-01
In Commercial Distribution
HES-034-10CH
Conformis, Inc.
FEMORAL HIP STEM COLLARED SZ 10 HIGH OFFSET
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64708 | Coated femoral stem prosthesis, one-piece |
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K231178 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e70c9ea2-d17f-41b3-ac2e-f64a309ff4c2
July 04, 2023
1
June 26, 2023
July 04, 2023
1
June 26, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
781-345-9001
customer-service@conformis.com
customer-service@conformis.com