DEVICE: pezo-A™ PEEK cage family (04052536016730)
Device Identifier (DI) Information
pezo-A™ PEEK cage family
CS 3331-10
In Commercial Distribution
CS 3331-10
Ulrich GmbH & Co. KG
CS 3331-10
In Commercial Distribution
CS 3331-10
Ulrich GmbH & Co. KG
pezo-A, height 10 mm, length x width 28 x 22 mm, angle 8°
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Polymeric spinal fusion cage, sterile | A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral fusion device with bone graft, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K103814 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e37b7db0-7f15-42e1-88bc-dcde2c90fad8
July 06, 2018
3
July 30, 2016
July 06, 2018
3
July 30, 2016
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
[?]
+4907319654152
safety@ulrichmedical.com
safety@ulrichmedical.com