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510(k) K133893

STERISPINE LC CAGE by Safe Orthopaedics — Product Code MAX

K133893 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 March 14, 2014. 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
March 14, 2014
Date Received
December 20, 2013
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)
  • K130632 — STERISPINE PS PEDICLE SCREW (May 3, 2013)
  • K122021 — STERISPINE LC CAGE (September 20, 2012)

Other clearances for product code MAX

  • 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)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources