FDA.reportPublic FDA data

KeyLift™

Primary DI
B1830770000290
Brand
KeyLift™
Company
FLOSPINE LLC
Model
KeyLift™
Catalog number
07-7000-029
Device description
Mallet
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
B1830770000290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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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