FDA.reportPublic FDA data

DYNAMIS™ Navigation System

Primary DI
00810152100936
Brand
DYNAMIS™ Navigation System
Company
PROMETHEAN RESTORATIVE LLC
Model
SI0211
Catalog number
SI0211
Device description
NAVIGATION TRAY LID
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152100936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152100936008101521009368101521009360810152100936

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
Premarket exempt
true
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
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23
00840456214084JMUJMU DENTAL, INCFSM2026-06-23
00840456214091JMUJMU DENTAL, INCFSM2026-06-23
00840456214107JMUJMU DENTAL, INCFSM2026-06-23
00840456214114JMUJMU DENTAL, INCFSM2026-06-23
00840456214121JMUJMU DENTAL, INCFSM2026-06-23
00840456215098JMUJMU DENTAL, INCFSM2026-06-23
00840456215111JMUJMU DENTAL, INCFSM2026-06-23
00840456215128JMUJMU DENTAL, INCFSM2026-06-23
00840456217580JMUJMU DENTAL, INCFSM2026-06-23