FDA.report

ASTRA Spine System

Primary DI
00193082059933
Brand
ASTRA Spine System
Company
SPINECRAFT, LLC
Model
A5M-8525-C
Catalog number
A5M-8525-C
Device description
ASTRA Ti Cannulated Monoaxial Screw DIA. 8.50 x 25mm
Published
2019-02-14
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

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral pedicle screw system

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193082059933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082059933001930820599331930820599330193082059933

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
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008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
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