DEVICE: MiniTi (06009712641666)
Device Identifier (DI) Information
MiniTi
ATP003
In Commercial Distribution
ATP003
ORTHO-DESIGN (PTY) LTD
ATP003
In Commercial Distribution
ATP003
ORTHO-DESIGN (PTY) LTD
MiniTi™, Titanium Suture Anchor, 2 x 6mm, w/Needles, 2 Sutures
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? |
---|---|---|---|---|
45062 | Tendon/ligament bone anchor, non-bioabsorbable |
A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K212381 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 2 Millimeter |
Device Record Status
198973a4-1651-43c0-a81a-12c3034fed59
August 07, 2024
4
September 01, 2023
August 07, 2024
4
September 01, 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 |
---|---|---|---|---|---|
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
[?]
+27128075172
dianpeach@ortho-design.co.za
dianpeach@ortho-design.co.za