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Reef TA TA1-136112

by SeaSpine Orthopedics Corporation

Reef TA TA1-136112 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K192132 on 3 Dec 2019 and listed in FDA GUDID since 7 May 2020 (UDI-DI 10889981193195), active as of 23 Oct 2026. One FDA recall is linked to it.

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

This device is named in the recall

Documents

510(k) K192132

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889981193195 UDI-DI Date7 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192132 Date3 Dec 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192132 decided 3 Dec 2019 Active
  • FDA GUDID UDI-DI 10889981193195 listed 7 May 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2554-2025 FDA Class II initiated 6 Aug 2025

    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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K192132
  2. Listed FDA GUDID 10889981193195
  3. Recall initiated FDA recalls Z-2554-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reef TA
Generic name
Metal-polymer composite spinal interbody fusion cage
Model / Ref / Catalog
TA1-136112
Primary DI / UDI-DI
10889981193195
FDA product code
MAX
GMDN term
Metal-polymer composite spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metal-polymer composite spinal interbody fusion cage

Cleared under the same submission (K192132)

and 8 more cleared under K192132

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

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, all answered No)