DEVICE: SonicAnchor (07613327096118)
Device Identifier (DI) Information
SonicAnchor
1910-1261S
In Commercial Distribution
1910-1261S
Stryker Trauma GmbH
1910-1261S
In Commercial Distribution
1910-1261S
Stryker Trauma GmbH
SONICANCHOR KIT
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? |
---|---|---|---|---|
45061 | Tendon/ligament bone anchor, bioabsorbable |
A 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 can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE |
HTY | PIN, FIXATION, SMOOTH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter: 2.5 Millimeter |
Length: 10.0 Millimeter |
Device Record Status
0b892efe-bfe8-47ca-b636-7a1bc8d4b8c0
March 21, 2019
4
September 24, 2015
March 21, 2019
4
September 24, 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 |
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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
[?]
No Customer Contact currently defined