FDA.reportPublic FDA data

Santis Non Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.35mm

Primary DI
07640159550433
Brand
Santis Non Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.35mm
Company
Lanterna Medical Technologies GmbH
Model
601-6535
Device description
Santis Non Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.35mm
Published
2014-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159550433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159550433076401595504337640159550433

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
+41712800930info@lanternamedtech.com

Regulatory Flags#

DUNS number
486405637
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640159550013Santis Locking Cap005-56702014-09-03
07640159550020Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.30mm501-55302014-09-03
07640159550037Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.35mm501-55352014-09-03
07640159550044Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.40mm501-55402014-09-03
07640159550051Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.45mm501-55452014-09-03
07640159550068Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.50mm501-55502014-09-03
07640159550075Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5mm/Lng.55mm501-55552014-09-03
07640159550082Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.35mm501-65352014-09-03
07640159550099Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.40mm501-65402014-09-03
07640159550105Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm501-65452014-09-03
07640159550112Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.50mm501-65502014-09-03
07640159550129Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5mm/Lng.55mm501-65552014-09-03
07640159550136Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.35mm501-75352014-09-03
07640159550143Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.40mm501-75402014-09-03
07640159550150Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.45mm501-75452014-09-03
07640159550167Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.50mm501-75502014-09-03
07640159550174Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.55mm501-75552014-09-03
07640159550181Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5mm/Lng.60mm501-75602014-09-03
07640159550198Santis Cannulated Reduction Polyaxial Pedicle Screw/Dia.5.5mm/Lng.30mm701-55302014-09-03
07640159550204Santis Cannulated Reduction Polyaxial Pedicle Screw/Dia.5.5mm/Lng.35mm701-55352014-09-03

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