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510(k) K972183

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL by Ace Medical Co. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
June 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Ace Medical Co.

  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • 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)
  • K912598 — ACE CORTICAL BONE SCREW (November 27, 1991)

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