FDA.reportPublic FDA data

OMNI

Primary DI
00840916108052
Brand
OMNI
Company
SPINAL ELEMENTS
Model
LCPT 40-K
Device description
Keyed Bullet Rod 40mm
Published
2017-06-28
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
00840916108052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916108052008409161080528409161080520840916108052

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
00840916108007OMNILCPT 120-K2017-06-27
00840916108014OMNILCPT 130-K2017-06-27
00840916108021OMNILCPT 140-K2017-06-27
00840916108038OMNILCPT 150-K2017-06-27
00840916108045OMNILCPT 35-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
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNH2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
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
00840019936798Sure-Lok Extended Tab Pedicle Screw SystemPRECISION SPINE, INC.MNH2019-09-03