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ROMEO Posterior Osteosynthesis System ELL-PS 08 80-S

by Spineart

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 Number07640139345899 UDI-DI Date21 Oct 2015ListedStatusListed 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  • Withdrawn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
ROMEO Posterior Osteosynthesis System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
ELL-PS 08 80-S
Primary DI / UDI-DI
07640139345899
FDA Product Code
KWP, MNH, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Size
Length — 80 Millimeter
Outer Diameter — 8 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Spineart

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Properties

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

Other properties (7)

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