FDA.reportPublic FDA data

LOTUS

Primary DI
00840606105132
Brand
LOTUS
Company
SPINAL ELEMENTS, INC.
Model
32035-016
Device description
Ø3.5MM X 16MM POLYAXIAL SCREW
Published
2019-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00840606105132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606105132008406061051328406061051320840606105132

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)607-0121info@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613154170166OASYSStryker CorporationKWP2015-09-14
07613154345014MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345021MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345038MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345045MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345052MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345069MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345090MAC TITANIUMStryker CorporationKWP2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationKWP2014-12-08
07613153045892XIA IIStryker CorporationKWP2014-12-08
07613153045908XIA IIStryker CorporationKWP2014-12-08
07613153045915XIA IIStryker CorporationKWP2014-12-08
07613153045922XIA IIStryker CorporationKWP2014-12-08