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510(k) K853438

H-H HUNTER ACTIVE TENDON IMPLANT by Holter-Hausner Intl. — Product Code HXA

K853438 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H HUNTER ACTIVE TENDON IMPLANT". The FDA issued a decision of SN on September 30, 1985. 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
SN ()
Decision Date
September 30, 1985
Date Received
August 15, 1985
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)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (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)
  • K853437 — H-H HUNTER TENDON ROD (October 16, 1985)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (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)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K781943 — TENDON ROD MODEL OR41PO3-6 (December 4, 1978)
  • K780320 — PASSIVE TENDON IMPLANT (March 17, 1978)

FDA data resources