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510(k) K151276

DePuy Synthes T-PAL Ti Spacer by Synthes USA Products, LLC — Product Code MAX

K151276 is an FDA 510(k) premarket notification submitted by Synthes USA Products, LLC for the device "DePuy Synthes T-PAL Ti Spacer". The FDA issued a decision of Substantially Equivalent on June 18, 2015. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Synthes USA Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2015
Date Received
May 13, 2015
Clearance Type
Special
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 Synthes USA Products, LLC

  • K180541 — DePuy Synthes 2.0 mm Quick Insertion Screws (November 21, 2018)
  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K170654 — USS System (March 29, 2017)
  • K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated S (February 16, 2017)
  • K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (November 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System (January 20, 2015)
  • K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (September 25, 2014)
  • K133698 — SYNAPSE SYSTEM (January 16, 2014)

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