FDA.reportPublic FDA data

Synergy Disc Instruments

Primary DI
M67091000009250
Brand
Synergy Disc Instruments
Company
Synergy Spine Solutions Inc
Model
910-00009-25
Catalog number
910-00009-25
Device description
Trial, Small, 5mm, 6°
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLQManual Instruments Designed For Use With Total Disc Replacement Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253392000Synergy Disc InstrumentsSynergy Spine Solutions, Inc.2026-03-27QLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M67091000009250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(720) 787-9064raqa@synergyspinesolutions.com

Regulatory Flags#

DUNS number
144962703
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M670107751700Synergy Disc Instruments1077-51701077-51702026-04-17
M670107751900Synergy Disc Instruments1077-51901077-51902026-04-17
M6709100000101Synergy Disc Instruments910-00001910-000012026-04-17
M670910000021205Synergy Disc Instruments910-00002-12910-00002-122026-04-17
M670910000021407Synergy Disc Instruments910-00002-14910-00002-142026-04-17
M670910000021609Synergy Disc Instruments910-00002-16910-00002-162026-04-17
M670910000022206Synergy Disc Instruments910-00002-22910-00002-222026-04-17
M670910000022408Synergy Disc Instruments910-00002-24910-00002-242026-04-17
M6709100000303Synergy Disc Instruments910-00003910-000032026-04-17
M6709100000707Synergy Disc Instruments910-00007910-000072026-04-17
M670910000080109Synergy Disc Instruments910-00008-01910-00008-012026-04-17
M67091000008020Synergy Disc Instruments910-00008-02910-00008-022026-04-17
M67091000009150Synergy Disc Instruments910-00009-15910-00009-152026-04-17
M67091000009160Synergy Disc Instruments910-00009-16910-00009-162026-04-17
M67091000009260Synergy Disc Instruments910-00009-26910-00009-262026-04-17
M67091000009350Synergy Disc Instruments910-00009-35910-00009-352026-04-17
M67091000009360Synergy Disc Instruments910-00009-36910-00009-362026-04-17
M67091000009450Synergy Disc Instruments910-00009-45910-00009-452026-04-17
M67091000009460Synergy Disc Instruments910-00009-46910-00009-462026-04-17
M67091000009550Synergy Disc Instruments910-00009-55910-00009-552026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M670107751700Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670107751900Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000101Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021205Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021407Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021609Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022206Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022408Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000303Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000707Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000080109Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000008020Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009150Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009160Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009260Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009350Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009360Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009450Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009460Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009550Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009560Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009650Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009660Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010750Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010760Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010850Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010860Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010950Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010960Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100001102Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17