DEVICE: MetaCun™ Locking Plate (04048266076373)
Device Identifier (DI) Information
MetaCun™ Locking Plate
27
Not in Commercial Distribution
FH03027
Merete GmbH
27
Not in Commercial Distribution
FH03027
Merete GmbH
TiAl6V4 ELI non-sterile
Device Characteristics
Labeling does not contain MRI Safety Information | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46647 | Orthopaedic fixation plate, non-bioabsorbable |
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102688 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 27 Millimeter |
Device Record Status
9e431594-a27b-4367-87dd-a0636725f85b
February 01, 2024
6
October 15, 2015
February 01, 2024
6
October 15, 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(630)869-1092
service@merete.medical.com
service@merete.medical.com