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510(k) K853436

H-H HUNTER PASSIVE TENDON IMPLANT by Holter-Hausner Intl. — Product Code HXR

K853436 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H HUNTER PASSIVE TENDON IMPLANT". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code HXR (Spatula, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
August 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • 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)
  • 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)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)

Other clearances for product code HXR

  • K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL (March 15, 1999)
  • K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM (November 25, 1987)
  • K872281 — RAYLOR FUSION FUNNEL (November 2, 1987)

FDA data resources