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DYNAMIS™ Implant System

FDA UDI

Class II (US FDA UDI)

by Promethean Restorative

Identity

Trade Name
DYNAMIS™ Implant System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
DYNAMIS™ SCREW DIA 9.5 X 90MM FDA UDI
Model / Reference
SI09590-S FDA UDI
Description
DYNAMIS™ SCREW DIA 9.5 X 90MM FDA UDI

Identifiers

Catalog Number
SI09590-S FDA UDI
Primary DI / UDI-DI
10810152101527 FDA UDI
510(k) Number
K243565 FDA UDI
K251075 FDA UDI
FDA Product Code
OUR FDA UDI
HWC FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 9.5 Millimeter FDA UDI
Length — 90 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbableSacroiliac joint transarticular fixation/arthrodesis implant, uncoated

DYNAMIS™ Implant System by Promethean Restorative — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated.

Cleared under the same submission

K243565 also covers:

K251075 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Promethean Restorative

Sources (1)

  • FDA UDI 8dbdae5d-7763-4e27-ad19-9c3597fabec4 37 fields · synced May 30, 2026