510(k) K910031

PARK CITY SHOULDER POSITIONER by Orthopedic Systems, Inc. — Product Code FWZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 24, 1991
Date Received: January 4, 1991
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Operating Room Accessories Table Tray
Device Class: Class I
Regulation Number: 878.4950
Review Panel: SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
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)
K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)
K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
K895219 — CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM (September 12, 1989)

Other clearances for product code FWZ

K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
K935381 — KAPS POSITIONING ARM (April 15, 1994)
K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (July 30, 1993)
K926225 — SPONGE COUNTER (March 5, 1993)
K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
K905564 — PREP AND OPERATING STAND (February 21, 1991)
K904826 — TKO TELESCOPING LITHOTOMY STIRRUP (October 31, 1990)