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IlluminOss SY-3500-01

by IlluminOss Medical

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

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

De Novo DEN160062

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM986SY3500010 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN160062 Date19 Dec 2017DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

GUDID

Trade name
IlluminOss
Generic name
Orthopaedic bone pin, non-bioabsorbable
Model / Ref / Catalog
SY-3500-01
Primary DI / UDI-DI
M986SY3500010
De Novo Number
FDA product code
QAD
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class II
Regulation number
888.3023
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from IlluminOss Medical

See all devices from IlluminOss Medical →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Serial number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Single use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No