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Sfs 55-2145

by Orthofix US LLC

Sfs 55-2145 is a Class II device made by Orthofix US LLC, cleared under FDA 510(k) K211710 on 30 Jul 2021 and listed in FDA GUDID since 17 Jul 2026 (UDI-DI 18257200054312), 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) K211710

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 Number18257200054312 UDI-DI Date17 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211710 Date30 Jul 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211710 decided 30 Jul 2021 Active
  • FDA GUDID UDI-DI 18257200054312 listed 17 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211710
  2. Listed FDA GUDID 18257200054312

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sfs
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
55-2145
Primary DI / UDI-DI
18257200054312
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

Related devices

Cleared under the same submission (K211710)

and 8 more cleared under K211710

Other devices from Orthofix US LLC

See all devices from Orthofix US LLC →

Properties

  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)