FDA.reportPublic FDA data

NA

Primary DI
03663136024417
Brand
NA
Company
SPINEVISION
Model
TL1-A020
Device description
Curved rongeur 10mm
Published
2016-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136024417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136024417036631360244173663136024417

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33153332525corp.quality@spinevision.com

Regulatory Flags#

DUNS number
390377518
Device count
1
DM exempt
false
Premarket exempt
true
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
03663136009308Hexanium® ACIFAC2-A012-M11L2025-02-20
03663136009315Hexanium® ACIFAC2-A012-M09L2025-02-20
03663136009322Hexanium® ACIFAC2-A012-M07L2025-02-20
03663136009339Hexanium® ACIFAC2-A012-M05L2025-02-20
03663136009346Hexanium® ACIFAC2-A012-S11L2025-02-20
03663136009353Hexanium® ACIFAC2-A012-S09L2025-02-20
03663136009360Hexanium® ACIFAC2-A012-S07L2025-02-20
03663136009384Hexanium® ACIFAC2-A012-L11C2025-02-20
03663136009391Hexanium® ACIFAC2-A012-L09C2025-02-20
03663136009407Hexanium® ACIFAC2-A012-L07C2025-02-20
03663136009414Hexanium® ACIFAC2-A012-L05C2025-02-20
03663136009421Hexanium® ACIFAC2-A012-M11C2025-02-20
03663136009438Hexanium® ACIFAC2-A012-M09C2025-02-20
03663136009445Hexanium® ACIFAC2-A012-M07C2025-02-20
03663136009452Hexanium® ACIFAC2-A012-M05C2025-02-20
03663136009469Hexanium® ACIFAC2-A012-S11C2025-02-20
03663136009476Hexanium® ACIFAC2-A012-S09C2025-02-20
03663136009483Hexanium® ACIFAC2-A012-S07C2025-02-20
03663136009490Hexanium® ACIFAC2-A012-S05C2025-02-20
03663136009261Hexanium® ACIFAC2-A012-L11L2025-02-19

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