Home / 510(k) Clearances / K240181

510(k) K240181

Clavicle and Scapula System by Auxein Medical Pvt., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances for product code HRS

  • K260090 — SMART Osteotomy System (April 10, 2026)
  • K253718 — enHAnce PEEK Bunion System (April 1, 2026)
  • K260274 — Airlock® Ankle Plating System (March 25, 2026)
  • K260291 — Vortex5 Tailor's Bunion Correction System (March 25, 2026)
  • K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5 (March 24, 2026)
  • K254288 — Clavicle Fixation System (March 23, 2026)
  • K260448 — CastleLoc Pectus Bar System (March 19, 2026)
  • K260390 — Super Upper Limbs Versalock Plating System (March 17, 2026)
  • K254053 — APS Spear Locking Plate (March 17, 2026)
  • K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (March 16, 2026)