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510(k) K953961

OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM by Osteonics Corp. — Product Code FWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Pneumatic
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

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  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)

Other clearances for product code FWW

  • K935356 — CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (March 23, 1994)
  • K931876 — FISK ARM SUPPORT (September 9, 1993)
  • K924713 — UNIVERSAL SURGICAL INSTRUMENT HOLDER (May 17, 1993)
  • K863161 — TABLE, OPERATING ROOM, HYDRAULIC (September 5, 1986)
  • K853479 — SKYTRON ELITE 300 SURGERY TABLE (September 5, 1985)