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510(k) K160222

OIC Cervical PEEK Spacer by The Orthopaedic Implant Company — Product Code ODP

K160222 is an FDA 510(k) premarket notification submitted by The Orthopaedic Implant Company for the device "OIC Cervical PEEK Spacer". The FDA issued a decision of Substantially Equivalent on December 7, 2016. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. The Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2016
Date Received
January 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by The Orthopaedic Implant Company

  • K242995 — OIC Small / Mini Fragment Plate System (October 23, 2024)
  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)
  • K223761 — OIC Intramedullary Screw System (February 13, 2023)
  • K223118 — OIC Variable Angle Small Fragment Locking Plate System (January 21, 2023)
  • K212601 — DRPx Locking Distal Radius Plate System (April 5, 2022)
  • K202971 — DRPx Locking Distal Radius Plate System (May 6, 2021)
  • K211112 — OIC External Fixation System (May 5, 2021)
  • K183682 — OIC External Fixation System (April 8, 2019)
  • K182736 — OIC Suture Anchor System (December 28, 2018)
  • K181184 — OIC Intramedullary Nail System (July 27, 2018)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources