FDA.report

ASTRA Spine System

Primary DI
00193082054716
Brand
ASTRA Spine System
Company
SPINECRAFT, LLC
Model
A5R-55FL-025
Catalog number
A5R-55FL-025
Device description
ASTRA DIA. 5.5mm Ti MIS Fixed Lordosed Rod, 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
MNIOrthosis, spinal pedicle fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193082054716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082054716001930820547161930820547160193082054716

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
true
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

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00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
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