FDA.reportPublic FDA data

Liberty

Primary DI
M9438000020000
Brand
Liberty
Company
Spinal Simplicity, LLC
Model
80-0002-000
Device description
Extractor
Published
2025-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9438000020000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
963359513
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9433500130000Freedom DS35-0013-0002026-05-07
M9432002100000Minuteman20-0210-0002026-05-05
M9432002110000Minuteman 20-0211-0002026-05-05
M9432002120000Minuteman 20-0212-0002026-05-05
M9432002130000Minuteman 20-0213-0002026-05-05
M9432002140000Minuteman 20-0214-0002026-05-05
M9432002160000Minuteman20-0216-0002026-05-05
M9432002170000Minuteman 20-0217-0002026-05-05
M9432002180000Minuteman 20-0218-0002026-05-05
M9432002190000Minuteman 20-0219-0002026-05-05
M9432002210000Minuteman 20-0221-0002026-05-05
M9433000290000Minuteman30-0029-0002026-05-05
M9433500120000Minuteman 35-0012-0002026-05-05
M9431002200000Minuteman 10-0220-0002026-02-23
M9431002210000Minuteman 10-0221-0002026-02-23
M9431002220000Minuteman 10-0222-0002026-02-23
M9431002230000Minuteman 10-0223-0002026-02-23
M9431002240000Minuteman 10-0224-0002026-02-23
M9432001910000Patriot SI20-0191-0002024-05-13
M9438000060000Liberty SI80-0006-0002025-11-17

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Primary DI, Brand, Company table
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00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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