FDA.reportPublic FDA data

TRANSITION

Primary DI
00849044023497
Brand
TRANSITION
Company
GLOBUS MEDICAL, INC.
Model
152.042S
Device description
TRANSITION 1 Level Implant, Lordosed, 22mm
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073439000TRANSITION STABILIZATION SYSTEMGlobus Medical, Inc.2009-02-20NQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849044023497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849044023497008490440234978490440234970849044023497

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
00193982586430CAPTIVATE3188.25153188.25152026-06-10
00193982586454CAPTIVATE3188.25173188.25172026-06-10
00193982586478CAPTIVATE3188.25193188.25192026-06-10
00193982586690CAPTIVATE3188.26143188.26142026-06-10
00193982586706CAPTIVATE3188.26153188.26152026-06-10
00193982586713CAPTIVATE3188.26163188.26162026-06-10
00193982586720CAPTIVATE3188.26173188.26172026-06-10
00193982586737CAPTIVATE3188.26183188.26182026-06-10
00193982586744CAPTIVATE3188.26193188.26192026-06-10
00193982586973CAPTIVATE3188.30113188.30112026-06-10
00193982586997CAPTIVATE3188.30133188.30132026-06-10
00193982587017CAPTIVATE3188.30153188.30152026-06-10
00193982587031CAPTIVATE3188.30173188.30172026-06-10
00193982587055CAPTIVATE3188.30193188.30192026-06-10
00193982587277CAPTIVATE3188.31143188.31142026-06-10
00193982587284CAPTIVATE3188.31153188.31152026-06-10
00193982587291CAPTIVATE3188.31163188.31162026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20763000313344CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-17
20613994170174CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2016-07-08
00613994123732CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123749CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123800CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123824CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123831CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123909CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123916CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123923CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123985CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123992CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124012CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124074CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994188540CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197382CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197412CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197344CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197375CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197719CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197788CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197795CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197726CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994197757CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994177193CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188502CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188519CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188533CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188571CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18