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510(k) K950618

ACE SUPRACONDYLAR PLATE by Ace Medical Co. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
February 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)
  • 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)
  • K912598 — ACE CORTICAL BONE SCREW (November 27, 1991)

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