DEVICE: OptiMesh 1500 E (M7403302205)

Device Identifier (DI) Information

OptiMesh 1500 E
10-10-04-9
In Commercial Distribution
330-2205
SPINEOLOGY INC.
M7403302205
HIBCC

1
033014361 *Terms of Use
Surgical Mesh
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
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
Vertebral body bone graft pouch A sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EZX Mesh, surgical, metal
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K014200 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 27 Millimeter
CLOSE

Device Record Status

69a78ec4-f78f-4201-9ab8-f641946e0d90
July 06, 2018
3
September 04, 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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(651)256-8500 534
jhauge@spineology.com
CLOSE