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Oyster S-OCT-10151405-S

by Silony Medical GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04054896061870 UDI-DI Date5 Sep 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Oyster
Generic Name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
S-OCT-10151405-S
Primary DI / UDI-DI
04054896061870
FDA Product Code
ODP
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Millimeter
Width — 14 Millimeter
Height — 10 Millimeter

Related devices

Category: Polymeric spinal fusion cage, sterile

Other devices from Silony Medical GmbH

See all devices from Silony Medical GmbH →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No