FDA.reportPublic FDA data

Santis Cannulated Reduction Extra LongPolyaxial Pe

Primary DI
07640159551348
Brand
Santis Cannulated Reduction Extra LongPolyaxial Pe
Company
Lanterna Medical Technologies GmbH
Model
901-6550
Device description
Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.50mm
Published
2014-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159551348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159551348076401595513487640159551348

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07640159550013Santis Locking Cap005-56702014-09-03
07640159550020Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55302014-09-03
07640159550037Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55352014-09-03
07640159550044Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55402014-09-03
07640159550051Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55452014-09-03
07640159550068Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55502014-09-03
07640159550075Santis Cannulated Polyaxial Pedicle Screw/Dia.5.5m501-55552014-09-03
07640159550082Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5m501-65352014-09-03
07640159550099Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5m501-65402014-09-03
07640159550105Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5m501-65452014-09-03
07640159550112Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5m501-65502014-09-03
07640159550129Santis Cannulated Polyaxial Pedicle Screw/Dia.6.5m501-65552014-09-03
07640159550136Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75352014-09-03
07640159550143Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75402014-09-03
07640159550150Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75452014-09-03
07640159550167Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75502014-09-03
07640159550174Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75552014-09-03
07640159550181Santis Cannulated Polyaxial Pedicle Screw/Dia.7.5m501-75602014-09-03
07640159550198Santis Cannulated Reduction Polyaxial Pedicle Scre701-55302014-09-03
07640159550204Santis Cannulated Reduction Polyaxial Pedicle Scre701-55352014-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
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06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
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06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22