Skip to content

Bremer Halo System Cervical Traction Skull Pin

by Bremer Medical, Inc. 510(k)

Active United States

510(k) K915800

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915800 Date16 Mar 1992ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-0134-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0130-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0132-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0141-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0140-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0143-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0144-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0133-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0131-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0135-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0136-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0138-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0137-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0142-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)
    • Terminated Z-0139-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006 via K915800, on the same 510(k)

    Sterility of device is compromised due to loss of package integrity

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
JEC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Bremer Medical, Inc.