DEVICE: C-VBR (10888857403697)
Device Identifier (DI) Information
C-VBR
Lordotic-M-21.5
Not in Commercial Distribution
STGC-LCM21.5
K2M, INC.
Lordotic-M-21.5
Not in Commercial Distribution
STGC-LCM21.5
K2M, INC.
Corpectomy Cage, Lordotic, Size 12x14x21.5 mm
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? |
---|---|---|---|---|
34170 | Vertebral body prosthesis |
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PLR | Spinal vertebral body replacement device - Cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152568 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 12 Millimeter |
Width: 14 Millimeter |
Height: 21.5 Millimeter |
Angle: 9 degree |
Device Record Status
b6c4e83c-ed57-4c26-9894-5a3a42d794b0
February 24, 2020
4
March 26, 2018
February 24, 2020
4
March 26, 2018
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(703)777-3155
sgilbert@k2m.com +1(703)777-3155
mzellers@k2m.com
sgilbert@k2m.com +1(703)777-3155
mzellers@k2m.com