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510(k) K003618

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 by Whiteside Biomechanics, Inc. — Product Code NDD

K003618 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014". The FDA issued a decision of Substantially Equivalent on May 23, 2001. The device falls under product code NDD (Cerclage, Fixation, Metallic), a Class II device regulated under 21 CFR 888.3010. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
November 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation, Metallic
Device Class
Class II
Regulation Number
888.3010
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)
  • K993903 — WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 (February 14, 2000)
  • K991678 — WHITESIDE BIOMECHANICS SPINAL SYSTEM (August 12, 1999)
  • 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)

FDA data resources