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VerteGlide Spinal Growth Guidance System 00-1725-4512

by Orthopediatrics Corp.

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 23 Oct 2026

Documents

510(k) K241816

FDA submission, from GUDID

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 Number00840194464871 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241816 Date14 Mar 2025DecidedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
VerteGlide Spinal Growth Guidance System
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
00-1725-4512
Primary DI / UDI-DI
00840194464871
510(k) Number
FDA product code
PGM
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K241816)

Show all (12)

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (10)

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