FDA.reportPublic FDA data

InTess Lumbar Cage

Primary DI
B07312K0103080
Brand
InTess Lumbar Cage
Company
Kalitec Direct LLC
Model
12-K01-0308
Device description
Shaver, Closed, 8mm
Published
2018-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07312K0103080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal curetteA hand-held, sterile surgical instrument used to scrape and score the cancellous vertebral bone of the spine, typically during a percutanous, minimally-invasive procedure. It consists of a long, thin, metal shaft that terminates distally in a mushroom-like cutting head that can be set at alternative angles (up to ninety degrees). The device enables a smooth scoring action for the creation of grooves or channels, and is typically used as an adjunct device in the treatment of vertebral compression fractures (VCFs) during kyphoplasty. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041956211
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
false
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
B07315K0112220NIDO Pedicle Screw System15-K01-122215-K01-12222025-03-19
B07315K0112300NIDO Pedicle Screw System15-K01-123015-K01-12302025-03-19
B07315CLA50100NIDO Pedicle Screw System15-CLA-501015-CLA-50102024-09-19
B07315CLA51100NIDO Pedicle Screw System15-CLA-511015-CLA-51102024-09-19
B07330TNS27070Navagio Lumbar Cage30-TNS-270730-TNS-27072024-08-12
B07330TTS27070Navagio Lumbar Cage30-TTS-270730-TTS-27072024-08-12
B07311K0130400Cosmolock11-K01-304011-K01-30402024-06-20
B07315K0120120NIDO Pedicle Screw System15-K01-201215-K01-20122024-05-31
B07315K0120100NIDO Pedicle Screw System15-K01-201015-K01-20102024-05-02
B07315K0170000NIDO Pedicle Screw System15-K01-700015-K01-70002024-03-01
B07310BRS02300Cosmolock10-BRS-023010-BRS-02302024-01-16
B07315BCC05000NIDO Pedicle Screw System15-BCC-050015-BCC-05002023-10-06
B07315BCC05050NIDO Pedicle Screw System15-BCC-050515-BCC-05052023-10-06
B07315BCC05100NIDO Pedicle Screw System15-BCC-051015-BCC-05102023-10-06
B07315BCC05150NIDO Pedicle Screw System15-BCC-051515-BCC-05152023-10-06
B07315BCC05250NIDO Pedicle Screw System15-BCC-052515-BCC-05252023-10-06
B07315BCC05300NIDO Pedicle Screw System15-BCC-053015-BCC-05302023-10-06
B07315BCC05350NIDO Pedicle Screw System15-BCC-053515-BCC-05352023-10-06
B07315BCC05400NIDO Pedicle Screw System15-BCC-054015-BCC-05402023-10-06
B07315BCC05450NIDO Pedicle Screw System15-BCC-054515-BCC-05452023-10-06

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