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510(k) K881060

OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) by Orthopedic Systems, Inc. — Product Code JEA

K881060 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)". The FDA issued a decision of Substantially Equivalent on March 25, 1988. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1988
Date Received
March 4, 1988
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 Orthopedic Systems, Inc.

  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K920256 — SPINE MOTION ANALYZER WITH EMG (August 10, 1992)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)

Other clearances for product code JEA

  • K953071 — STRYKER COMMAND2 OFFICE CONSOLE (August 8, 1995)
  • K924094 — MEND APC (March 30, 1993)
  • 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)
  • 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