FDA.reportPublic FDA data

Panama™

Primary DI
B1830870000210
Brand
Panama™
Company
FLOSPINE LLC
Model
Panama™
Catalog number
08-7000-021
Device description
AO Self Retaining Driver
Published
2021-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
B1830870000210PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
5617053080info@flospine.com

Regulatory Flags#

DUNS number
042993143
Device count
1
DM exempt
false
Premarket exempt
true
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
B1830171000120Canaveral®Canaveral®01-7100-0122025-04-04
B1830172000360Canaveral®Canaveral®01-7200-0362025-04-04
B1830172000370Canaveral®Canaveral®01-7200-0372025-04-04
B183FSBMHN1104X0Bone Marrow Harvest NeedleFS-BMHN1104XFS-BMHN1104X2025-04-04
B183FSDBANJ0806TL0Bone Acess NeedleFS-DBANJ0806TLFS-DBANJ0806TL2025-04-04
B183FSDBANJ1106TL0Bone Acess NeedleFS-DBANJ1106TLFS-DBANJ1106TL2025-04-04
B1830112000010Canaveral®Canaveral®01-1200-0012016-06-30
B1830112450500Canaveral®Canaveral®01-1245-0502025-03-28
B1830111450500Canaveral®Canaveral®01-1145-0502025-03-26
B1830113450500Canaveral®Canaveral®01-1345-0502025-03-24
B1830113550300Canaveral®Canaveral®01-1355-0302025-03-24
B1830113650250Canaveral®Canaveral®01-1365-0252025-03-24
B1830112150300Canaveral®Canaveral®01-1215-0302016-06-30
B1830112150350Canaveral®Canaveral®01-1215-0352016-06-30
B1830112150600Canaveral®Canaveral®01-1215-0602016-06-30
B1830112151000Canaveral®Canaveral®01-1215-1002016-06-30
B1830112151100Canaveral®Canaveral®01-1215-1102016-06-30
B1830112450350Canaveral®Canaveral®01-1245-0352016-06-30
B1830112450400Canaveral®Canaveral®01-1245-0402016-06-30
B1830112450450Canaveral®Canaveral®01-1245-0452016-06-30

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Primary DI, Brand, Company table
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00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
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10885862657060CSBExactech, Inc.HXX2026-01-28
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00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
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00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
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