Skip to content

PressON Pedicle Screw System 520483S

by Nexus Spine, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberB678520483S0 UDI-DI Date31 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PressON Pedicle Screw System
Generic Name
Bone-screw internal spinal fixation system rod
Model / Reference
520483S
Primary DI / UDI-DI
B678520483S0
510(k) Number
FDA Product Code
NKB
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Size
Length — 45 Millimeter

Related devices

Cleared under the same submission (K223529)

Show all (12)

Other devices from Nexus Spine, L.L.C.

See all devices from Nexus Spine, L.L.C. →

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