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Chesapeake (Cervical Components)

by K2M, Inc.

510(k) K111439

Chesapeake (Cervical Components) is a Class II device made by K2M, Inc., cleared under FDA 510(k) K111439 on 24 Aug 2011, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK111439 Date24 Aug 2011ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1410-2021 FDA Class II initiated 16 Mar 2021 on shared 510(k) K111439

    Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K111439
  2. Recall initiated FDA recalls Z-1410-2021

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  • Withdrawn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
OVE
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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