FDA.reportPublic FDA data

APEX-DL Spine System

Primary DI
00193082033049
Brand
APEX-DL Spine System
Company
SPINECRAFT, LLC
Model
DMR6-4735
Catalog number
DMR6-4735
Device description
APEX Ti Mono Double Lead Thread Reduction Screw Dia.4.75, 35mm
Published
2019-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082033049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082033049001930820330491930820330490193082033049

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(630)920-7300info@spinecraft.com

Regulatory Flags#

DUNS number
783908713
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193082163166ASTRA-OCT Spine System6600-01L6600-01L2025-03-17
00193082163173ASTRA-OCT Spine System6600-T15-3L6600-T15-3L2025-03-17
00193082163180ORIO7020-02-08B7020-02-08B2025-01-30
00193082163197ORIO7020-02-10B7020-02-10B2025-01-30
00193082163203ORIO7020-02-12B7020-02-12B2025-01-30
00193082155888ASTRA Spine System6300-966300-962024-11-08
00193082155895APEX Spine System6000-14-L36000-14-L32024-11-08
00193082155901APEX Spine System6000-14-R36000-14-R32024-11-08
00193082155918APEX Spine System6000-14-L46000-14-L42024-11-08
00193082155925APEX Spine System6000-14-R46000-14-R42024-11-08
00193082155932ASTRA-OCT Spine System6600-8506600-8502024-11-08
00193082156700ASTRA Spine SystemA6L-OTL150A6L-OTL1502024-11-08
00193082156717ASTRA Spine SystemA6L-OT015A6L-OT0152024-11-08
00193082156724ASTRA Spine SystemA6L-OT150A6L-OT1502024-11-08
00193082163029ASTRA Spine System6300-89C-PSN6300-89C-PSN2024-11-08
00193082163050ASTRA Spine System6300-97-R6300-97-R2024-11-08
00193082163067APEX Spine SystemF6-1837F6-18372024-11-08
00193082163074APEX Spine SystemF6-1834F6-18342024-11-08
00193082163081APEX Spine SystemF6-1831F6-18312024-11-08
00193082163098ASTRA Spine SystemA5D-C4A5D-C42024-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000794675CD HORIZON ESSENCE™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-08-14
00763000788018CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-07-10
00763000787837CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-06-14
00763000788001CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-15
00763000787813CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-04
00763000872236CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-03
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