DEVICE: OsteoCove (10889981309084)
Device Identifier (DI) Information
OsteoCove
56930150
In Commercial Distribution
56930150
SEASPINE ORTHOPEDICS CORPORATION
56930150
In Commercial Distribution
56930150
SEASPINE ORTHOPEDICS CORPORATION
OsteoCove Strip, 15cc
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
47967 | Bone matrix implant, composite |
A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K230486 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
31ec00f3-b982-42ec-989b-122a7c1b6f31
November 07, 2023
1
October 30, 2023
November 07, 2023
1
October 30, 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 |
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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