DEVICE: DELTA (37613327598415)
Device Identifier (DI) Information
DELTA
77-22204
In Commercial Distribution
77-22204
Stryker Leibinger GmbH & Co. KG
77-22204
In Commercial Distribution
77-22204
Stryker Leibinger GmbH & Co. KG
Delta s-tap screw 20 PK
Device Characteristics
| MR Safe | |
| 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? |
|---|---|---|---|---|
| 46637 | Craniofacial bone screw, bioabsorbable |
A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JEY | PLATE, BONE |
| HBW | FASTENER, PLATE, CRANIOPLASTY |
| DZL | SCREW, FIXATION, INTRAOSSEOUS |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K230733 | 000 |
| K231208 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: less than 49 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Diameter: 2.2 Millimeter |
| Length: 4.0 Millimeter |
Device Record Status
615dff2d-1084-445f-a4d6-6a4ab9820625
January 27, 2025
1
January 17, 2025
January 27, 2025
1
January 17, 2025
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:
07613327598414
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined