DEVICE: Profemur (00192629250192)
Device Identifier (DI) Information
Profemur
PRGCME12
In Commercial Distribution
PRGCME12
Microport Orthopedics Inc.
PRGCME12
In Commercial Distribution
PRGCME12
Microport Orthopedics Inc.
PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 12 EXTENDED
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
33989 | Uncoated 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 not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
KWL | Prosthesis, hip, hemi-, femoral, metal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K201519 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6fdc0acd-5c92-495f-a98b-b84c29a7fd30
December 29, 2020
1
December 21, 2020
December 29, 2020
1
December 21, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M684PRGCME121 |
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
[?]
+1(866)872-0211
Stephen.Weaver@ortho.microport.com
Stephen.Weaver@ortho.microport.com