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510(k) K780320

PASSIVE TENDON IMPLANT by Holter-Hausner Intl. — Product Code HXA

K780320 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "PASSIVE TENDON IMPLANT". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code HXA (Prosthesis, Tendon, Passive), a Class II device regulated under 21 CFR 888.3025. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1978
Date Received
February 24, 1978
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 Holter-Hausner Intl.

  • K875287 — H-H FLUSHING RESERVOIR (July 14, 1988)
  • K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (January 19, 1988)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K871351 — H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (May 14, 1987)
  • K870660 — H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (May 1, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)
  • K853437 — H-H HUNTER TENDON ROD (October 16, 1985)

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)
  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)
  • K781943 — TENDON ROD MODEL OR41PO3-6 (December 4, 1978)

FDA data resources