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510(k) K260570

corra™ cervical plating system by Carlsmed, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2026
Date Received
February 19, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Carlsmed, Inc.

  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
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  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbod (July 7, 2025)
  • K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device (June 30, 2025)
  • K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu (March 17, 2025)
  • K242599 — aprevo® Digital Planning (December 20, 2024)
  • K243635 — aprevo® anterior lumbar interbody fusion device with interfixation (December 13, 2024)
  • K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (November 15, 2024)
  • K241477 — aprevo® anterior lumbar interbody fusion device with interfixation (October 9, 2024)

Other clearances for product code KWQ

  • K252776 — ARIES Anterior Cervical Plate Systems (May 14, 2026)
  • K261112 — CastleLoc-P Anterior Cervical Plate System (May 6, 2026)
  • K260697 — VyPlate™ Anterior Cervical Plate System (March 27, 2026)
  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)