DEVICE: DELTA (07613252645054)
Device Identifier (DI) Information
DELTA
70-92043
In Commercial Distribution
70-92043
Stryker Leibinger GmbH & Co. KG
70-92043
In Commercial Distribution
70-92043
Stryker Leibinger GmbH & Co. KG
Delta 2.2mm Panel 3x21 Ctrsinks x 1.4mm
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? |
---|---|---|---|---|
46641 | Craniofacial fixation plate, bioabsorbable |
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | Fastener, fixation, biodegradable, soft tissue |
HBW | FASTENER, PLATE, CRANIOPLASTY |
JEY | PLATE, BONE |
GXR | COVER, BURR HOLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K213777 | 000 |
K993061 | 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: Thickness: 1.4 Millimeter |
Device Size Text, specify: 3D Plates: 3x21 Holes |
Device Record Status
766db43b-42ed-4ce8-a547-0a6feaeb1df3
September 18, 2023
9
September 24, 2015
September 18, 2023
9
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 |
---|---|---|---|---|---|
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
[?]
No Customer Contact currently defined