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510(k) K872858

WILLIAMS VERTEBRAL SPREADER by Ace Medical Co. — Product Code HXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
July 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Bending Or Contouring
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Ace Medical Co.

  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K972183 — DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL (August 26, 1997)
  • K955472 — ACE HUMERUS & RADIUS PLATES (April 1, 1996)
  • K955388 — ACE-DUPONT COMPOSITE RINGS (January 31, 1996)
  • K954485 — 6.5MM SOLID CANCELLOUS BONE SCREW (October 31, 1995)
  • K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS (October 12, 1995)
  • K950618 — ACE SUPRACONDYLAR PLATE (May 10, 1995)
  • K933968 — ACE PELVIC STABILIZER (June 16, 1994)
  • K931652 — ACE 6.5 MM BONE SCREW (April 28, 1994)
  • K930592 — ACE UNIVERSAL RECONSTRUCTION PLATE (July 26, 1993)

Other clearances for product code HXP

  • K800733 — DOUBLE-EDGE CURETTE (April 8, 1980)
  • K800731 — MENISCAL SAW (April 8, 1980)
  • K800732 — MENISCOTOME (April 8, 1980)
  • K800730 — RETROGRADE KNIFE (April 8, 1980)