Cosmolock 11-RRC-0180
GUDID B07311RRC01800
Rod, Curved, 5.50 x 180mm
Kalitec Direct LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | B07311RRC01800 |
| NIH Device Record Key | 5236079a-2b51-4a77-942c-994484e902cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cosmolock |
| Version Model Number | 11-RRC-0180 |
| Catalog Number | 11-RRC-0180 |
| Company DUNS | 041956211 |
| Company Name | Kalitec Direct LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B07311RRC01800 [Primary] |
FDA Product Code
| MNI | Orthosis, Spinal Pedicle Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
[B07311RRC01800]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-10 |
| Device Publish Date | 2021-09-02 |
On-Brand Devices [Cosmolock]
| B07311K0361090 | Distractor, Fixed Tip |
| B07311K0361080 | Compressor, Fixed Tip |
| B07310K0197010 | Assembly, Compressor - Distractor Lever, Full MIS |
| B07310K0123000 | Recovery Tube, MIS |
| B07311K1100140 | Implant Tray, Cosmolock, Arcamed |
| B07311K1100110 | Tray Insert 4, Cosmolock, Arcamed |
| B07311K1100100 | Tray Insert 3, Cosmolock, Arcamed |
| B07311K1100090 | Tray Insert 2, Cosmolock, Arcamed |
| B07311K1100080 | Tray Insert 1, Cosmolock, Arcamed |
| B07311K0600130 | Tray Insert 3, Cosmolock Deformity |
| B07311K0600120 | Tray Insert 5, Cosmolock Deformity |
| B07310K0690140 | Tray Insert, MIS Lumbar Instrument 3 |
| B0731010K0690150 | Tray Insert, MIS Lumbar Instrument 4 |
| B07311K0170200 | Handheld Fascia Dilator |
| B07311K0140120 | Guide, Anti-Splay |
| B07311K0130120 | Segmental Rod Reducer Driver |
| B07311K0130110 | Segmental Rod Reducer, Slim, Assembly |
| B07311K0130100 | Segmental Rod Reducer Assembly |
| B07311K0100210 | Caddie Lid, Rods, 5.5mm |
| B07311K0100200 | Caddie, Rods, 5.5mm Assembly |
| B07311K0100060 | Tray Insert, Lumbar Screws, 10 x 10 Assembly |
| B07311K1430210 | Rod Template, 500mm |
| B07311K1430200 | Rod Template, 250mm |
| B07311K0316920 | Probe, 1.75" Egg, Steffee, Long, Straight, Impact |
| B07311K0150050 | Sizer, Fixed Crosslink Assembly |
| B07311K0120220 | Assembly, Screwdriver, Extended Tab |
| B07311K0120210 | Assembly, Screwdriver, Extended Tab, Cannulated, Lockable |
| B07311K0120150 | Assembly, Screwdriver, Polyaxial, Lockable |
| B073DRK0100280 | Tab Breaker, Single Sided, Cosmolock MIS |
| B07310K1190140 | Tray Insert 6, Cosmo MIS,Arcamed |
| B07310K1190130 | Tray Insert 5, Cosmo MIS,Arcamed |
| B07310K1190120 | Tray Insert 4, Cosmo MIS, Arcamed |
| B07310K1190100 | Tray Insert 3, Cosmo MIS, Arcamed |
| B07310K1190090 | Tray Insert 2, Cosmo MIS, Arcamed |
| B07310K1190080 | Tray Insert 1, Cosmo MIS, Arcamed |
| B07310K0690130 | Tray Insert, MIS Lumbar Instruments 2 |
| B07310K0690120 | Tray Insert, MIS Lumbar Instruments 1 |
| B07310K0690100 | Tray Insert, MIS Lumbar Implants 3 |
| B07310K0690090 | Tray Insert, MIS Lumbar Implants 2 |
| B07310K0690080 | Tray Insert, MIS Lumbar Implants |
| B073DRK0100300 | Sagittal Bender, Straight |
| B07311RRC02000 | Rod, Curved, 5.50 x 200mm |
| B07311RRC01900 | Rod, Curved, 5.50 x 190mm |
| B07311RRC01800 | Rod, Curved, 5.50 x 180mm |
| B07311RRC01700 | Rod, Curved, 5.50 x 170mm |
| B07311RRC01600 | Rod, Curved, 5.50 x 160mm |
| B07311RRC01500 | Rod, Curved, 5.50 x 150mm |
| B07311RRC01400 | Rod, Curved, 5.50 x 140mm |
| B07311RRC01300 | Rod, Curved, 5.50 x 130mm |
| B07310NTN06100 | Guidewire, NiTi Trocar, Non-Threaded 610mm |
Trademark Results [Cosmolock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COSMOLOCK 85810036 4602203 Live/Registered |
Kalitec Direct, LLC 2012-12-24 |
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