FDA.reportPublic FDA data

CAPTIVATE

Primary DI
00193982586430
Brand
CAPTIVATE
Company
GLOBUS MEDICAL, INC.
Model
3188.2515
Catalog number
3188.2515
Device description
CAPTIVATE Sola Headless Compression Screw, 2.5x15mm, Short Thread, Ti
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982586430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982586430001939825864301939825864300193982586430

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
139105691
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
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
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
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
00193982587307CAPTIVATE3188.31173188.31172026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606798Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606804Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606811Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606828Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606835Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606842Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606859Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606866Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606873Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606880Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606897Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606903Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606910Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258609775Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30