FDA.reportPublic FDA data

Catalyft™ LS Expandable Interbody System

Primary DI
00763000952808
Brand
Catalyft™ LS Expandable Interbody System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
981304555
Device description
SCREW 981304555 4.5 X 55MM SINGLE LEAD
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241992000Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2024-10-28OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000952808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000952808007630009528087630009528080763000952808

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169328716N/A30029332017-12-09
00763000891503CD HORIZON Spinal System559006195502026-09-28
00763000891527CD HORIZON Spinal System559006101502026-09-28
00763000891541CD HORIZON Spinal System559016101502026-09-28
00763000891558CD HORIZON Spinal System559016101602026-09-28
00763000891572CD HORIZON Spinal System559016175502026-09-28
00763000891589CD HORIZON Spinal System559016175602026-09-28
00763000891602CD HORIZON Spinal System559016185502026-09-28
00763000891619CD HORIZON Spinal System559016185602026-09-28
00763000891626CD HORIZON Spinal System559016195502026-09-28
00763000891633CD HORIZON Spinal System559016195602026-09-28
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.OVD2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCOVD2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19