FDA.reportPublic FDA data

SANTIS™ ADJUSTABLE TRANVERSE CONNECTORS- 45MM-60MM - STERILE

Primary DI
07640159552703
Brand
SANTIS™ ADJUSTABLE TRANVERSE CONNECTORS- 45MM-60MM - STERILE
Company
Lanterna Medical Technologies GmbH
Model
300-5545-S
Device description
SANTIS™ ADJUSTABLE TRANVERSE CONNECTORS- 45MM-60MM - 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
07640159552703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159552703076401595527037640159552703

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationNKB2014-12-08
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07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045762XIA IIStryker CorporationMNH2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
07613153045793XIA IIStryker CorporationMNH2014-12-08
07613153045793XIA IIStryker CorporationMNI2014-12-08
07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045847XIA IIStryker CorporationMNH2014-12-08