FDA.reportPublic FDA data

OMNI

Primary DI
00840916108007
Brand
OMNI
Company
SPINAL ELEMENTS
Model
LCPT 120-K
Device description
Keyed Bullet Rod 120mm
Published
2017-06-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916108007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916108007008409161080078409161080070840916108007

GMDN Terms#

Term, Definition table
TermDefinition
Public respirator bodyA form-shaped filtering mask designed to be fitted with an appropriate filter(s) [not included] and placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/headstraps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916156176TALONTL22342020-05-05
00840916156183TALONTL22352020-05-05
00840916156190TALONTL22362020-05-05
00840916156206TALONTL22372020-05-05
00840916156213TALONTL22382020-05-05
00840916107208OMNICT050502017-06-19
00840916107215OMNICT050552017-06-19
00840916107253OMNICT060502017-06-19
00840916107291OMNICT070452017-06-19
00840916107307OMNICT070502017-06-19
00840916107987OMNILCPT 100-K2017-06-27
00840916108014OMNILCPT 130-K2017-06-27
00840916108021OMNILCPT 140-K2017-06-27
00840916108038OMNILCPT 150-K2017-06-27
00840916108045OMNILCPT 35-K2017-06-28
00840916108052OMNILCPT 40-K2017-06-28
00840916108069OMNILCPT 45-K2017-06-28
00840916108076OMNILCPT 50-K2017-06-28
00840916108083OMNILCPT 55-K2017-06-28
00840916108090OMNILCPT 60-K2017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
00840916152413TALONSPINAL ELEMENTSMNH2020-04-14
00840916152420TALONSPINAL ELEMENTSMNH2020-04-14
00840916152437TALONSPINAL ELEMENTSMNH2020-04-14
00840916152444TALONSPINAL ELEMENTSMNH2020-04-14
00840916152529TALONSPINAL ELEMENTSMNH2020-04-14
00840916152536TALONSPINAL ELEMENTSMNH2020-04-14
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
00840916109837TALONSPINAL ELEMENTSMNH2017-07-10
00840916109844TALONSPINAL ELEMENTSMNH2017-07-10
00840916109851TALONSPINAL ELEMENTSMNH2017-07-10
00840916109868TALONSPINAL ELEMENTSMNH2017-07-10
00840916109875TALONSPINAL ELEMENTSMNH2017-07-10
00840916109882TALONSPINAL ELEMENTSMNH2017-07-10
00840916109899TALONSPINAL ELEMENTSMNH2017-07-10
00840916109905TALONSPINAL ELEMENTSMNH2017-07-10
00840916109912TALONSPINAL ELEMENTSMNH2017-07-10
00840916109929TALONSPINAL ELEMENTSMNH2017-07-10
00840916109950OMNISPINAL ELEMENTSMNH2017-07-10
00840916109967TALONSPINAL ELEMENTSMNH2017-07-10
00840916109974TALONSPINAL ELEMENTSMNH2017-07-10
00840916109981TALONSPINAL ELEMENTSMNH2017-07-10