FDA.reportPublic FDA data

SANTIS™ PRE BENT ROD 5.5mm X50mm -STERILE

Primary DI
07640159551690
Brand
SANTIS™ PRE BENT ROD 5.5mm X50mm -STERILE
Company
Lanterna Medical Technologies GmbH
Model
101-0050-S
Device description
SANTIS™ PRE BENT ROD 5.5mm X50mm -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

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
07640159551690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159551690076401595516907640159551690

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

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
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
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12