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510(k) K930125

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

K930125 is an FDA 510(k) premarket notification submitted by Phoenix Bioengineering, Inc. for the device "PHOENIX BONE SCREWS PBS-TYPE SERIES". The FDA issued a decision of Substantially Equivalent on December 30, 1993. The device falls under product code HXA (Prosthesis, Tendon, Passive), a Class II device regulated under 21 CFR 888.3025. Phoenix Bioengineering, Inc. has at least 2 other 510(k) clearances on record.

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)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (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)

FDA data resources