FDA.reportPublic FDA data

Omega

Primary DI
00840606197342
Brand
Omega
Company
SPINAL ELEMENTS, INC.
Model
11422-100
Device description
Inserter Locking Driver
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606197342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606197342008406061973428406061973420840606197342

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7606070121customerservice@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00840606197472OMEGA XP11441-0002026-10-29
00840606190671Primus66675-0202026-10-26
00840466901011Primus66027-0452026-10-22
00840606168472SAPPHIRE X27002-0232026-10-22
00840606168502SAPPHIRE X27002-0292026-10-22
00840606174855Primus66102-0002026-10-22
00840606175142Primus66647-0002026-10-22
00840606175203Primus66656-0002026-10-22
00840606175234Primus66685-0002026-10-22
00840606176347Lucent11341-1122026-10-22
00840606184656Overwatch108-159-01C2026-10-22
00840606184847Lucent11341-5122026-10-22
00840606185820Primus66599-0002026-10-22
00840606185868Primus66675-0102026-10-22
00840606186506Lateral81077-0082026-10-22
00840606186513Lateral81077-0102026-10-22
00840606186575SAPPHIRE X27001-0002026-10-22
00840606186612SAPPHIRE X27001-000-042026-10-22
00840606186643SAPPHIRE X27001-000-072026-10-22
00840606186674SAPPHIRE X27001-000-102026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308486047INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
08800308486054INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
00841731133717REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
00841731133724REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
08800322759233Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08800322759240Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809695602887Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974815953Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974816004Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08