DEVICE: MiniTi (06009712641666)

Device Identifier (DI) Information

MiniTi
ATP003
In Commercial Distribution
ATP003
ORTHO-DESIGN (PTY) LTD
06009712641666
GS1

1
557386523 *Terms of Use
MiniTi™, Titanium Suture Anchor, 2 x 6mm, w/Needles, 2 Sutures
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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
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FDA Product Code

[?]
Product Code Product Code Name
MBI Fastener, Fixation, Nondegradable, Soft Tissue
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K212381 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2 Millimeter
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Device Record Status

198973a4-1651-43c0-a81a-12c3034fed59
August 07, 2024
4
September 01, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+27128075172
dianpeach@ortho-design.co.za
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