FDA.reportPublic FDA data

SANTIS™CAN. REDUC POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STERILE

Primary DI
07640159551997
Brand
SANTIS™CAN. REDUC POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STERILE
Company
Lanterna Medical Technologies GmbH
Model
701-5540-S
Device description
SANTIS™CAN. REDUC POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STERILE
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

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
07640159551997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159551997076401595519977640159551997

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486405637
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
18257200054206SFSOrthofix US LLCNKB2026-07-17
18257200054213SFSOrthofix US LLCNKB2026-07-17
18257200054220SFSOrthofix US LLCNKB2026-07-17
18257200054237SFSOrthofix US LLCNKB2026-07-17
18257200054244SFSOrthofix US LLCNKB2026-07-17
18257200054251SFSOrthofix US LLCNKB2026-07-17
18257200054268SFSOrthofix US LLCNKB2026-07-17
18257200054275SFSOrthofix US LLCNKB2026-07-17
18257200054282SFSOrthofix US LLCNKB2026-07-17
18257200054299SFSOrthofix US LLCNKB2026-07-17
18257200054305SFSOrthofix US LLCNKB2026-07-17
18257200054312SFSOrthofix US LLCNKB2026-07-17
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13