Cosmolock 11-K01-0020

GUDID B07311K0100200

Caddie, Rods, 5.5mm Assembly

Kalitec Direct LLC

Surgical instrument/implant rack

• Primary Device ID: B07311K0100200
• NIH Device Record Key: 75120447-8106-4100-bcb8-c244d8900fba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cosmolock
• Version Model Number: 11-K01-0020
• Catalog Number: 11-K01-0020
• Company DUNS: 041956211
• Company Name: Kalitec Direct LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	B07311K0100200 [Primary]

FDA Product Code

• LRP: Tray, Surgical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B07311K0100200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-03

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