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Ossera™ AFX 1740-3640

by Restor3D

Ossera™ AFX 1740-3640 is a Class II device made by Restor3D, cleared under FDA 510(k) K242356 on 24 Mar 2025 and listed in FDA GUDID since 18 Dec 2025 (UDI-DI 00840097534770), active as of 23 Oct 2026.

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) K242356

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 Number00840097534770 UDI-DI Date18 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242356 Date24 Mar 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242356 decided 24 Mar 2025 Active
  • FDA GUDID UDI-DI 00840097534770 listed 18 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242356
  2. Listed FDA GUDID 00840097534770

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ossera™ AFX
Generic name
Metallic osteotomy fusion cage, non-customized
Model / reference
1740-3640
Primary DI / UDI-DI
00840097534770
510(k) Number
FDA product code
SAI
GMDN term
Metallic osteotomy fusion cage, non-customized
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242356)

and 8 more cleared under K242356

Other devices from Restor3D

See all devices from Restor3D →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)