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510(k) K771020

SPINAL SURGERY FRAME by Orthopedic Systems, Inc. — Product Code JEB

K771020 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "SPINAL SURGERY FRAME". The FDA issued a decision of Substantially Equivalent on June 17, 1977. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1977
Date Received
June 6, 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 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 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)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)
  • K873274 — PLASTER TABLE 1418 (September 17, 1987)

FDA data resources