FDA.reportPublic FDA data

Synergy Disc Instruments

Primary DI
M67091000010860
Brand
Synergy Disc Instruments
Company
Synergy Spine Solutions Inc
Model
910-00010-86
Catalog number
910-00010-86
Device description
Pilot Cutter, Medium, 6mm
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
M67091000010860PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Millimeter

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
M67091000009250Synergy Disc Instruments910-00009-25910-00009-252026-04-17
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

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
M67091000009250Synergy 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
M67091000010950Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010960Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100001102Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17