DEVICE: RFS™ Screw (E302RFSC35369)
Device Identifier (DI) Information
RFS™ Screw
RFS-C3536
Not in Commercial Distribution
RFS-C3536
Bioretec Oy
RFS-C3536
Not in Commercial Distribution
RFS-C3536
Bioretec Oy
RFS™ Screw Cannulated 3.5 x 36 mm
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
45039 | Bioabsorbable orthopaedic bone screw |
A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K081392 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 3.5 Millimeter |
Length: 36 Millimeter |
Device Record Status
88950b18-0abd-4dd3-96f1-80d184163104
January 03, 2024
5
September 23, 2015
January 03, 2024
5
September 23, 2015
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 |
---|---|
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
[?]
+358207789500
sales@bioretec.com
sales@bioretec.com