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DYNAMIS™ Implant System SI09545-S

by Promethean Restorative

DYNAMIS™ Implant System SI09545-S is a Class II device made by Promethean Restorative, cleared under FDA 510(k) K251075 on 25 Apr 2025 (1 earlier submission) and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 10810152101435), active as of 9 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251075 Date25 Apr 2025DecidedStatusActive
United StatesGUDID listing Number10810152101435 UDI-DI Date5 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251075 decided 25 Apr 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10810152101435 listed 5 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243565
  2. Listed FDA GUDID 10810152101435
  3. Cleared FDA 510(k) K251075

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DYNAMIS™ Implant System
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
SI09545-S
Primary DI / UDI-DI
10810152101435
FDA product code
OUR, HWC
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 9.5 Millimeter
Length — 45 Millimeter

Related devices

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

Cleared under the same submission (K243565)

and 8 more cleared under K243565

Cleared under the same submission (K251075)

and 8 more cleared under K251075

Similar devices

Other devices filed under FDA product code OUR (Sacroiliac Joint Fixation).

Other devices from Promethean Restorative

See all devices from Promethean Restorative →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)