FDA.reportPublic FDA data

OMEGA XP

Primary DI
00840606186544
Brand
OMEGA XP
Company
SPINAL ELEMENTS, INC.
Model
11422-002
Device description
OMEGA XP INSERTER - AXIAL
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
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606186544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606186544008406061865448406061865440840606186544

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
00840606185929Primus66585-0032026-09-24
00840606185936Primus66586-0122026-09-24
00840606186773Primus66586-0142026-09-24
00840606186780Primus66586-0162026-09-24
00840606187237Primus66900-0202026-09-24
00840606187244Primus66900-020-012026-09-24
00840606187251Primus66900-020-022026-09-24
00840606174923Primus66545-0552026-09-22
00840606175036Primus66585-0002026-09-22
00840606175074Primus66515-0002026-09-22
00840606175098Primus66595-0002026-09-22
00840606175135Primus66650-0002026-09-22
00840606175241Primus66690-0002026-09-22
00840606185875Primus66675-0022026-09-22
00840606185899Primus66657-0002026-09-22
00840606186551OMEGA XP11412-2952026-09-22
00840606186797Primus66585-0042026-09-22
00840606190695Primus66910-0002026-09-22
00840606190701Primus66910-000-012026-09-22
00840606190718Primus66910-000-022026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
04546540147257XIA IIStryker CorporationKWP2014-12-08
04546540147769XIA IIStryker CorporationKWP2014-12-08
04546540147806XIA IIStryker CorporationKWP2014-12-08
04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08
04546540148018XIA IIStryker CorporationKWP2014-12-08
04546540148025XIA IIStryker CorporationKWP2014-12-08
04546540148735XIA IIStryker CorporationKWP2014-12-08
04546540148742XIA IIStryker CorporationKWP2014-12-08
04546540148759XIA IIStryker CorporationKWP2014-12-08
04546540148766XIA IIStryker CorporationKWP2014-12-08
04546540148773XIA IIStryker CorporationKWP2014-12-08
04546540148780XIA IIStryker CorporationKWP2014-12-08
04546540148797XIA IIStryker CorporationKWP2014-12-08
04546540148803XIA IIStryker CorporationKWP2014-12-08
04546540148810XIA IIStryker CorporationKWP2014-12-08
04546540148827XIA IIStryker CorporationKWP2014-12-08