Home / 510(k) Clearances / K772321

510(k) K772321

ARTHROSTRESS by Mtd, Inc. — Product Code JEB

K772321 is an FDA 510(k) premarket notification submitted by Mtd, Inc. for the device "ARTHROSTRESS". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Mtd, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
December 19, 1977
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 Mtd, Inc.

  • K063439 — MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS (January 22, 2007)
  • K833559 — ARMBOARD (January 3, 1984)
  • K791374 — THE MTD VARA SET CASETTE HOLDER (September 7, 1979)
  • K771659 — PATIENT RESTRAINT SYSTEM (September 30, 1977)

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)
  • K891387 — WILLIAMS BELT & BOOT (May 23, 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)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)

FDA data resources