DEVICE: PlusDrive (20887587042159)
Device Identifier (DI) Information
PlusDrive
400.054
In Commercial Distribution
400054
Synthes GmbH
400.054
In Commercial Distribution
400054
Synthes GmbH
1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 4MM
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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47635 | Implantable craniofacial bone distractor |
A non-powered implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JEY | PLATE, BONE |
| DZL | SCREW, FIXATION, INTRAOSSEOUS |
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| PBJ | Cranial Distraction System |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K102656 | 000 |
| K162594 | 000 |
| K170818 | 000 |
| K963546 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
449be650-4a3a-4688-b3e1-21a349eb5da5
March 06, 2025
6
September 14, 2015
March 06, 2025
6
September 14, 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 |
|---|---|
| HIBCC | H9804000540 |
Unit of Use DI
[?]
Unit of Use DI Number:
80887587042151
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx