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510(k) K891917

ORTHO-J, INC. BEK-JS-004 by Ortho-J, Inc. — Product Code JEB

K891917 is an FDA 510(k) premarket notification submitted by Ortho-J, Inc. for the device "ORTHO-J, INC. BEK-JS-004". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1989
Date Received
March 27, 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 for product code JEB

  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K891387 — WILLIAMS BELT & BOOT (May 23, 1989)
  • K881101 — K ORTHOPEDIC TABLE (April 6, 1988)
  • K880263 — OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION (March 15, 1988)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873274 — PLASTER TABLE 1418 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K781082 — CAST BLOCK (July 7, 1978)

FDA data resources