DEVICE: Mainstay (04546540792501)
Device Identifier (DI) Information
Mainstay
3910-002-035
Not in Commercial Distribution
3910-002-035
STRYKER CORPORATION
3910-002-035
Not in Commercial Distribution
3910-002-035
STRYKER CORPORATION
3.5MM MAINSTAY ZIP ANCHOR WITH ? CIRCLE CUTTING NEEDLE, 2 STRANDS #2 BRAIDED POLYESTER
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Tendon bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of soft tissues/tendons either directly or via a suture attached to the device; it is not dedicated to ligament anchoring. It is typically used in shoulder and some lower-limb operations, and functions as an alternative to drilling a hole in bone for passing a suture. 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)]. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDR | STAPLE, FIXATION, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K965175 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter: 3.5 Millimeter |
Device Record Status
889ac8ce-346d-441c-9572-9614c1bd437e
January 08, 2019
4
September 09, 2015
January 08, 2019
4
September 09, 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
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx