FDA.reportPublic FDA data

3.8mm CS Facet Compression Device

Primary DI
81195401029448
Brand
3.8mm CS Facet Compression Device
Company
INTERVENTIONAL SPINE, INC
Model
CS-38-2025
Catalog number
9031-03
Device description
3.8mm x 20-25mm
Published
2015-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
81195401029448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8119540102944881195401029448

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-497-0484www.cs@i-spineinc.com

Regulatory Flags#

DUNS number
017663522
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
000119540134488 Degree Lordotic, Opticage Expandable Interbody Implant9101-219101-212016-05-25
81195401082986Opticage Expandable Interbody Implant9080-009080-002015-09-14
81195401107962Opticage Expandable Interbody Implant9080-019080-012015-09-14
81195401108648Opticage Expandable Interbody Implant9080-029080-022015-09-14
81195401109393Opticage Expandable Interbody Implant9080-039080-032015-09-14
81195401110900Opticage Expandable Interbody Implant9080-049080-042015-09-14
81195401111686Opticage Expandable Interbody Implant9080-059080-052015-09-14
81195401112362Opticage Expandable Interbody Implant9080-069080-062015-09-14
81195401113048Opticage Expandable Interbody Implant9080-079080-072015-09-14
81195401114724Opticage Expandable Interbody Implant9080-089080-082015-09-14
81195401115400Opticage Expandable Interbody Implant9080-099080-092015-09-14
81195401116186Opticage Expandable Interbody Implant9080-109080-102015-09-14
81195401117862Opticage Expandable Interbody Implant9080-119080-112015-09-14
81195401245886Opticage Expandable Interbody Implant9080-129080-122015-09-23
81195401246562Opticage Expandable Interbody Implant9080-139080-132015-09-23
81195401247248Opticage Expandable Interbody Implant9080-149080-142015-09-23
81195401248924Opticage Expandable Interbody Implant9080-159080-152015-09-23
81195401249600Opticage Expandable Interbody Implant9080-169080-162015-09-23
81195401250286Opticage Expandable Interbody Implant9080-179080-172015-09-23
81195401251962Opticage Expandable Interbody Implant9080-189080-182015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCMRW2026-03-09
00810131880330T-Handle 3/16" ConnectionSURGENTEC, LLCMRW2026-03-09
00810131881252 6.5/7.0 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881726ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
00810131881788ION Cervical Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881795ION Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881832 7.5 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881856ION Metal Drill Guide - LargeSURGENTEC, LLCMRW2026-03-09
00810131881986 ION Caddy with Metal PlateSURGENTEC, LLCMRW2026-03-09
00810131882051 Facet Locator - LargeSURGENTEC, LLCMRW2026-03-09
00810131882068 Impactor LargeSURGENTEC, LLCMRW2026-03-09
00810131882075Serrated Rasp - LargeSURGENTEC, LLCMRW2026-03-09
00810131882174ION Large TraySURGENTEC, LLCMRW2026-03-09
00810131882402 6.0mm Drill BitSURGENTEC, LLCMRW2026-03-09
00810131882419Plastic Removal Sleeve - Standard - 7.0-7.5SURGENTEC, LLCMRW2026-03-09
00810131882426Plastic Removal Sleeve - Standard - 5.5-6.5SURGENTEC, LLCMRW2026-03-09
00810131882723ION Cervical TraySURGENTEC, LLCMRW2026-03-09
00810131882747ION Lumbar TraySURGENTEC, LLCMRW2026-03-09
00810131882754ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
03760418040667FFX Screw SC MEDICAMRW2025-11-26
03760418040674FFX Screw SC MEDICAMRW2025-11-26
03760418040681FFX Screw SC MEDICAMRW2025-11-26
03760418040698FFX Screw SC MEDICAMRW2025-11-26
03760418040704FFX Screw SC MEDICAMRW2025-11-26
03760418040711FFX Screw SC MEDICAMRW2025-11-26
03760418040728FFX Screw SC MEDICAMRW2025-11-26
03760418040735FFX Screw SC MEDICAMRW2025-11-26