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510(k) K873660

ROPER-TUKE ELBOW by Orthopedic Systems, Inc. — Product Code JDB

K873660 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ROPER-TUKE ELBOW". The FDA issued a decision of SN on January 6, 1988. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 6, 1988
Date Received
September 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
Review Panel
OR
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 JDB

  • K222807 — TEMA Elbow system - Line extension (October 26, 2022)
  • K193247 — LATITUDE EV™ Total Elbow Arthroplasty (August 5, 2020)
  • K182461 — LATITUDE EV Total Elbow Arthroplasty (December 27, 2018)
  • K171010 — Latitude EV Total Elbow Arthroplasty (August 31, 2017)
  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • K100562 — LATITUDE ELBOW PROSTHESIS (June 29, 2010)
  • K070787 — LATITUDE ELBOW PROTHESIS (August 24, 2007)
  • K070236 — SBI LATERAL RADIO CAPITELLUM (February 21, 2007)
  • K060438 — RHS (April 18, 2006)
  • K060038 — SBI RADIO-CAPITELLAR IMPLANT (March 30, 2006)

FDA data resources