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Reef TO TO1-924125

by SeaSpine Orthopedics Corporation

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K192132; other models may be affected

Documents

510(k) K192132

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 Number10889981191306 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192132 Date3 Dec 2019DecidedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2554-2025 FDA Class II initiated 6 Aug 2025 on shared 510(k) K192132

    Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reef TO
Generic name
Vertebral body prosthesis
Model / Ref / Catalog
TO1-924125
Primary DI / UDI-DI
10889981191306
FDA product code
OVE
GMDN term
Vertebral body prosthesis
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K192132)

Show all (12)

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • 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
  • Manufacturing date: No