Home / 510(k) Clearances / K991678

510(k) K991678

WHITESIDE BIOMECHANICS SPINAL SYSTEM by Whiteside Biomechanics, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1999
Date Received
May 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Whiteside Biomechanics, Inc.

  • K033313 — QUATRO M FEMORAL COMPONENT (July 28, 2004)
  • K012800 — SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM (May 3, 2002)
  • K003618 — WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-101 (May 23, 2001)
  • K993903 — WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 (February 14, 2000)
  • K981238 — BIPOLAR FEMORAL HEAD (August 21, 1998)
  • K973261 — WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD (November 24, 1997)
  • K964616 — QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT (August 7, 1997)
  • K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD (July 30, 1997)
  • K971718 — MICRO-SEAL ACETABULAR SYSTEM (July 23, 1997)
  • K964150 — WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (December 27, 1996)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)