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510(k) K930125

PHOENIX BONE SCREWS PBS-TYPE SERIES by Phoenix Bioengineering, Inc. — Product Code HXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1993
Date Received
January 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tendon, Passive
Device Class
Class II
Regulation Number
888.3025
Review Panel
OR
Submission Type

Other clearances by Phoenix Bioengineering, Inc.

  • K913490 — PHOENIX BURR HOLE BUTTON, BURR 1 (January 13, 1992)
  • K904434 — SEXTON CYSTOTOMY URINE PUMP (SCUP2) (February 1, 1991)

Other clearances for product code HXA

  • K243477 — Universal Tendon Spacer (January 10, 2025)
  • K000019 — SINGLE SIZE TENDON SPACER (March 29, 2000)
  • K973385 — OVAL SHAPES (December 5, 1997)
  • K964359 — AVANTA ORTHOPAEDICS TENDON SPACER (March 25, 1997)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)
  • K781943 — TENDON ROD MODEL OR41PO3-6 (December 4, 1978)
  • K780320 — PASSIVE TENDON IMPLANT (March 17, 1978)