FDA.reportPublic FDA data

KeyLift™

Primary DI
B1830770000210
Brand
KeyLift™
Company
FLOSPINE LLC
Model
KeyLift™
Catalog number
07-7000-021
Device description
Caliper
Published
2025-02-07
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
LYQAccessories, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYQAccessories, Fixation, Spinal Intervertebral BodyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1830770000210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561)705-3081info@flospine.com

Regulatory Flags#

DUNS number
042993143
Device count
1
DM exempt
true
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
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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