FDA.reportPublic FDA data

DYNAMIS™ Navigation System

Primary DI
00810152100752
Brand
DYNAMIS™ Navigation System
Company
PROMETHEAN RESTORATIVE LLC
Model
SI0200
Catalog number
SI0200
Device description
NAVIGATED LOCKING DRIVER
Published
2026-01-20
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252962000DYNAMIS™ Navigation SystemPromethean Restorative, LLC2026-01-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152100752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152100752008101521007528101521007520810152100752

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
720-512-5947info-PR@prometheanrestorative.com

Regulatory Flags#

DUNS number
124592779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152103203DYNAMIS™ Implant SystemSI0012SI00122026-03-03
00810152104118DYNAMIS™ Implant SystemSI0010SI00102026-03-03
00810152100011FUSIO™ SI Allograft SystemBI0001BI00012026-02-13
00810152100158FUSIO™ SI Allograft SystemBI0015BI00152026-02-13
00810152100196FUSIO™ SI Allograft SystemBI0019BI00192026-02-13
00810152100295FUSIO™ SI Allograft SystemBI0020BI00202026-02-13
00810152100332FUSIO™ SI Allograft SystemBI0021BI00212026-02-13
00810152100462FUSIO™ SI Allograft SystemCPS0017CPS00172026-02-13
00810152101391FUSIO™ SI Allograft SystemCPS0013CPS00132026-02-13
00810152102039FUSIO™ SI Allograft SystemCPS0016CPS00162026-02-13
00810152100004FUSIO SI Allograft SystemBI0001BI00012024-10-18
00810152101285FUSIO™ SI Allograft SystemCPS0005CPS00052025-03-05
00810152101339FUSIO™ SI Allograft SystemCPS0010CPS00102025-03-05
00810152100097FUSIO SI Allograft SystemBI0009BI00092024-10-18
00810152100516DYNAMIS™ Navigation SystemSI0220SI02202026-01-20
00810152100646DYNAMIS™ Navigation SystemSI0201SI02012026-01-20
00810152100653DYNAMIS™ Navigation SystemSI0202SI02022026-01-20
00810152100677DYNAMIS™ Navigation SystemSI0203SI02032026-01-20
00810152100684DYNAMIS™ Navigation SystemSI0204SI02042026-01-20
00810152100721DYNAMIS™ Navigation SystemSI0205SI02052026-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07