FDA.report

Cosmolock Pedicle Screw System

Primary DI
B07310SSE85451
Brand
Cosmolock Pedicle Screw System
Company
Kalitec Direct LLC
Model
10-SSE-8545
Catalog number
10-SSE-8545
Device description
SCREW, EXT TAB, 8.5MM X 45MM
Published
2017-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07310SSE85451PrimaryHIBCC0

GMDN Terms

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
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 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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