FDA.reportPublic FDA data

DYNAMIS™ Navigation System

Primary DI
00810152100929
Brand
DYNAMIS™ Navigation System
Company
Promethean Restorative, Inc.
Model
SI0210
Catalog number
SI0210
Device description
NAVIGATION TRAY BASE
Published
2026-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00810152100929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152100929008101521009298101521009290810152100929

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152100486DYNAMIS™ Implant SystemAF-SIDS-001AF-SIDS-0012025-11-10
00810152100493DYNAMIS™ Implant SystemAF-SIDS-002AF-SIDS-0022025-11-10
00810152100806DYNAMIS™ Implant SystemSI0065SI00652025-11-10
00810152100813DYNAMIS™ Implant SystemSI0056SI00562025-11-10
00810152100820DYNAMIS™ Implant SystemSI0057SI00572025-11-10
00810152100837DYNAMIS™ Implant SystemSI0058SI00582025-11-10
00810152100844DYNAMIS™ Implant SystemSI0066SI00662025-11-10
00810152100851DYNAMIS™ Implant SystemSI0014SI00142025-11-10
00810152100868DYNAMIS™ Implant SystemSI0015SI00152025-11-10
00810152100943DYNAMIS™ Implant SystemSI0025SI00252025-11-10
00810152103173DYNAMIS™ Implant SystemSI0004SI00042025-11-10
00810152103180DYNAMIS™ Implant SystemSI0024SI00242025-11-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376749297Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
00190376766140Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
00190376776941Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
00190376778358Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
04250337122104iLESSYS® Delta Access TrayJoimax GmbHFSM2026-10-28
04250337122111iLESSYS® Delta Resection TrayJoimax GmbHFSM2026-10-28
06954454000564COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000571COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000588COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000595COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000601COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001202COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001271COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
M739223000700Nav Instruments General TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739223000800Nav Instruments Pedicle Screws TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739253001012Discectomy Prep TrayCAPTIVA SPINE, INC.FSM2026-10-28
00889024702660OsseoFitZimmer, Inc.FSM2026-10-27
00889024702677OsseoFitZimmer, Inc.FSM2026-10-27
00889024702684OsseoFitZimmer, Inc.FSM2026-10-27
00889024702691OsseoFitZimmer, Inc.FSM2026-10-27
00889024702707OsseoFitZimmer, Inc.FSM2026-10-27
00889024702714OsseoFitZimmer, Inc.FSM2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMFBrainlab SEFSM2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)Brainlab SEFSM2026-10-27
04250337118497Vaporgrip® Bipo Sterilization TrayJoimax GmbHFSM2026-10-27
04250337119265TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
04250337119272TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21