FDA.reportPublic FDA data

Freedom DS

Primary DI
M9433500130000
Brand
Freedom DS
Company
Spinal Simplicity, LLC
Model
35-0013-000
Device description
Freedom DS Decompression System
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253523000Freedom DS™ Decompression SystemSpinal Simplicity2026-04-16HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9433500130000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
963359513
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9432002220000Minuteman20-0222-0002026-09-04
M9432002230000Liberty SI20-0223-0002026-08-19
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

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Primary DI, Brand, Company table
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00850003512044SteribiteSteribite, LLCHAE2026-08-27
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00850003512129SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
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