DEVICE: DELTA (04546540337627)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
DELTA
70-26010
In Commercial Distribution
70-26010
Stryker Leibinger GmbH & Co. KG
04546540337627
GS1

1
316153956 *Terms of Use
DELTA 2.6X10MM EMERGENCY SCREW, 1 EA
CLOSE

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 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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
GXR COVER, BURR HOLE
HBW FASTENER, PLATE, CRANIOPLASTY
JEY PLATE, BONE
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K213777 000
K993061 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 49 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 10.0 Millimeter
Device Size Text, specify: Diameter: 2.6 Millimeter
CLOSE

Device Record Status
6aed9697-e202-4c17-9edd-67ef5366e707
September 18, 2023
9
September 24, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE