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510(k) K924984

SPECIALIST(R) WALKER by Johnson & Johnson Orthopaedics, Inc. — Product Code FYH

K924984 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "SPECIALIST(R) WALKER". The FDA issued a decision of Substantially Equivalent on February 1, 1993. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1993
Date Received
October 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Extremity, Noninflatable, External, Sterile
Device Class
Class I
Regulation Number
878.3910
Review Panel
HO
Submission Type

Other clearances by Johnson & Johnson Orthopaedics, Inc.

  • K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI (December 6, 1994)
  • K935452 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (October 6, 1994)
  • K940190 — ULTIMA UNIPOLAR MODULAR HEAD (September 29, 1994)
  • K933275 — P.F.C. CERAMIC HIP HEAD (September 28, 1994)
  • K932595 — ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (September 20, 1994)
  • K931655 — P.F.C. BIPOLAR HIP SYSTEM (June 9, 1994)
  • K933867 — UNIVERSAL INSET PATELLA (June 6, 1994)
  • K935262 — P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA (June 3, 1994)
  • K931189 — P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET (February 9, 1994)
  • K931054 — TRICK MODULAR KNEE TIBIAL TRAY-POROUS (January 25, 1994)

Other clearances for product code FYH

  • K925145 — TRACE MODEL #'S 840, 841, 842, 845 (May 19, 1993)
  • K895092 — KUT-SHIELD (September 26, 1989)
  • K852558 — SPLINTS(ALL TYPE) (July 2, 1985)
  • K843400 — HYDRO-SPLINT A SPONGE-COMPRESS DRESS (October 24, 1984)
  • K821693 — J & J DIP WATER ADDITIVE (July 2, 1982)
  • K802522 — DELTA-LITE CASTING TAPE & SPLINTS (January 8, 1981)
  • K801436 — ORTHOPEDIC LOWER EXTREMITY SUSPENSION (June 26, 1980)

FDA data resources