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Cascadia Interbody System

by K2M, Inc. 3 variants

510(k) K172009

Cascadia Interbody System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K172009 on 14 Dec 2017, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172009 Date14 Dec 2017ClearedStatusActive

Official records

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1697-2021 FDA Class II initiated 7 May 2021
    • Terminated Z-1696-2021 FDA Class II initiated 7 May 2021
    • Terminated Z-1695-2021 FDA Class II initiated 7 May 2021

    Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

Timeline

4 dated events

  1. Cleared FDA 510(k) K172009
  2. Recall initiated FDA recalls Z-1697-2021
  3. Recall initiated FDA recalls Z-1696-2021
  4. Recall initiated FDA recalls Z-1695-2021

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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