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510(k) K914858

ACE OPEN-BACK HALO RING by Ace Medical Co. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1991
Date Received
October 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Ace Medical Co.

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  • 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)

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