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510(k) K122021

STERISPINE LC CAGE by Safe Orthopaedics — Product Code MAX

K122021 is an FDA 510(k) premarket notification submitted by Safe Orthopaedics for the device "STERISPINE LC CAGE". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Safe Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
July 10, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Safe Orthopaedics

  • K201648 — Sterispine™ PS (July 30, 2020)
  • K170528 — Sterispine™ PS (March 9, 2017)
  • K162531 — STERISPINE CC (December 29, 2016)
  • K151921 — STERISPINE PS (October 8, 2015)
  • K151747 — STERISPINE PS (October 5, 2015)
  • K151756 — STERISPINE LC CAGE (August 21, 2015)
  • K150092 — STERISPINE PS Pedicle Screw (February 10, 2015)
  • K140802 — STERISPINE PS (June 4, 2014)
  • K133893 — STERISPINE LC CAGE (March 14, 2014)
  • K130632 — STERISPINE PS PEDICLE SCREW (May 3, 2013)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)

FDA data resources