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510(k) K891387

WILLIAMS BELT & BOOT by Arthro-Medic, Inc. — Product Code JEB

K891387 is an FDA 510(k) premarket notification submitted by Arthro-Medic, Inc. for the device "WILLIAMS BELT & BOOT". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Arthro-Medic, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
March 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Arthro-Medic, Inc.

  • K933597 — AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (November 1, 1993)
  • K893598 — HYDRAULIC FOOT OPERATED STOOL (October 10, 1989)
  • K893597 — HYDRAULIC IV POLE (October 10, 1989)

Other clearances for product code JEB

  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K891917 — ORTHO-J, INC. BEK-JS-004 (May 26, 1989)
  • K881101 — K ORTHOPEDIC TABLE (April 6, 1988)
  • K880263 — OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION (March 15, 1988)
  • K873274 — PLASTER TABLE 1418 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)
  • K781082 — CAST BLOCK (July 7, 1978)

FDA data resources