Canaveral® 01-1245-030
GUDID B1830112450300
Reduction Polyaxial Screw Assembly, 4.5mm x 30mm
FLOSPINE LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | B1830112450300 |
| NIH Device Record Key | 7f07ad80-3de5-4e66-9c1b-1a22efe8eb46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Canaveral® |
| Version Model Number | Canaveral® |
| Catalog Number | 01-1245-030 |
| Company DUNS | 042993143 |
| Company Name | FLOSPINE 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 |
Customer Support Contacts
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com | |
| Phone | (561) 705-3080 |
| info@flospine.com |
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 30 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1830112450300 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141850
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
[B1830112450300]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2016-06-30 |
On-Brand Devices [Canaveral®]
| B183180050010 | Generic Instrument Tray |
| B183180040020 | Tray, Deformity Implant Case 1 |
| B183180040010 | Base, Deformity Implant Case 1 |
| B183180000100 | 5.5mm Rod Caddy |
| B183180000090 | 8.5mm Screw Caddy, Core Screw Set |
| B183180000080 | 7.5mm Screw Caddy, Core Screw Set |
| B183180000070 | 6.5mm Screw Caddy, Core Screw Set |
| B183180000060 | 5.5mm Screw Caddy, Core Screw Set |
| B183180000050 | 4.5mm Screw Caddy, Core Screw Set |
| B183180000040 | Set Screw Caddy, Core Screw Set |
| B183180000030 | Tray, Core Screw Set |
| B183180000020 | Lid, Canaveral Pedicle Screw System |
| B183180000010 | Base, Core Screw Set |
| B183173000090 | Nav Modular Screwdriver |
| B183173000080 | Nav Polyaxial Screwdriver |
| B183173000070 | Nav Screw Tap, 10.5mm |
| B183173000060 | Nav Screw Tap, 9.5mm |
| B183173000050 | Nav Screw Tap, 8.5mm |
| B183173000040 | Nav Screw Tap, 7.5mm |
| B183173000030 | Nav Screw Tap, 6.5mm |
| B183173000020 | Nav Screw Tap, 5.5mm |
| B183173000010 | Nav Screw Tap, 4.5mm |
| B183171000370 | Palm Ratcheting Handle |
| B183171000360 | 1/4" Adapter, Reducer |
| B183171000350 | Palm Handle, Hood Driver |
| B183171000340 | Hood Driver - Final Tightening |
| B183171000330 | Ratcheting Box Wrench |
| B183171000320 | In-Situ Bender 5.5mm, Right |
| B183171000310 | In-Situ Bender 5.5mm, Left |
| B183171000300 | Coronal Bender 5.5mm, Right |
| B183171000290 | Coronal Bender 5.5mm, Left |
| B183171000280 | Headbody Manipulator |
| B183171000270 | Closed Polyaxial Screwdriver, Short |
| B183171000260 | Reduction Crown |
| B183171000250 | In-Situ Rod Bender, Right |
| B183171000240 | In-Situ Rod Bender, Left |
| B183171000230 | Right Coronal Bender |
| B183171000220 | Left Coronal Bender |
| B183171000140 | T-Handle |
| B183171000130 | T-Handle Torque Wrench - 90inlb |
| B183171000120 | 2.4mm Drill (nonserile disposable) |
| B183171000110 | Driver - Final Tightening |
| B183171000100 | Power vice grips |
| B183171000090 | Derotation Tube |
| B183171000080 | Reduction, Derotation Tower |
| B183171000070 | Palm Style Non-Ratcheting Handle |
| B183171000060 | Monoaxial Screwdriver, Reduction |
| B183171000050 | Monoaxial Screwdriver, |
| B183171000040 | Polyaxial Screwdriver, Short Reduction |
| B183171000030 | Polyaxial Screwdriver, Short |
Trademark Results [Canaveral]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CANAVERAL 88037262 5773304 Live/Registered |
Decathlon S.A. 2018-07-13 |
 CANAVERAL 86316671 4749558 Live/Registered |
FloSpine LLC 2014-06-21 |
 CANAVERAL 78749571 3313983 Dead/Cancelled |
BLACK & DECKER CORPORATION, THE 2005-11-08 |
 CANAVERAL 76438537 2816250 Dead/Cancelled |
DECATHLON 2002-08-05 |
 CANAVERAL 75613914 2948171 Dead/Cancelled |
ORACLE AMERICA, INC. 1998-12-28 |
 CANAVERAL 75567175 not registered Dead/Abandoned |
Grupo Azucarero Mexico, S.A. de C.V. 1998-10-09 |
 CANAVERAL 74185148 not registered Dead/Abandoned |
American Tourister, Inc. 1991-07-15 |
 CANAVERAL 74044730 1643054 Dead/Cancelled |
Grupo Canaveral, Inc. 1990-04-02 |
 CANAVERAL 73465565 1344421 Dead/Cancelled |
American Tourister, Inc. 1984-02-13 |
 CANAVERAL 72146583 0762660 Dead/Expired |
CHANNEL MASTER CORPORATION 1962-06-11 |
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