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510(k) K924094

MEND APC by Mend Technologies, Inc. — Product Code JEA

K924094 is an FDA 510(k) premarket notification submitted by Mend Technologies, Inc. for the device "MEND APC". The FDA issued a decision of Substantially Equivalent on March 30, 1993. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Mend Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1993
Date Received
August 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Mend Technologies, Inc.

  • K883867 — CERVICAL BIOPSY INSTRUMENT (November 29, 1988)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)

Other clearances for product code JEA

  • K953071 — STRYKER COMMAND2 OFFICE CONSOLE (August 8, 1995)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K911522 — ARTHROBOT(TM) WRIST HOLDER ACCESSORY (April 29, 1991)
  • K900290 — SKYTRON MODEL 1100 AND MODEL 142 (February 20, 1990)
  • K894789 — DMI 250 SERIES POWER SURGERY TABLE (August 29, 1989)
  • K881060 — OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (March 25, 1988)
  • K874762 — ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (December 10, 1987)
  • K873079 — ARTHROBOT 100 UPPER LIMB POSITIONER (November 25, 1987)
  • K873080 — ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (November 25, 1987)

FDA data resources