FDA.reportPublic FDA data

CosmoLock Pedicle Screw System

Primary DI
B07311K0120120
Brand
CosmoLock Pedicle Screw System
Company
Kalitec Direct LLC
Model
11-K01-2012
Device description
Screwdriver, Polyaxial, Standard
Published
2018-09-18
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07311K0120120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable 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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Primary DI, Brand, Company table
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00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00810076338545Momentum MIS - Modified InstrumentUlrich Medical Usa, Inc.HXX2026-03-02
00199150066902Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-02-28
03662663128780PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXX2026-02-11
03662663129084Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXX2026-02-11
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
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10886982351586NASynthes GmbHHXX2026-02-10
10886982351593NASynthes GmbHHXX2026-02-10
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10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
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00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
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