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510(k) K850886

COMPRESSION HIP SCREW SYSTEM by Pfizer, Inc. — Product Code KIT

K850886 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "COMPRESSION HIP SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. Pfizer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
March 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type

Other clearances by Pfizer, Inc.

  • K181102 — ThermaCare Quick Therapy TENS (September 15, 2018)
  • K991620 — VISINE FOR CONTACTS (September 24, 1999)
  • K892264 — ORALCHEK SUPER-SOFT BRUSH (June 14, 1989)
  • K892360 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (June 5, 1989)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K854726 — MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (February 24, 1986)
  • K850413 — MEC HIP BOLT (July 15, 1985)
  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)
  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)

Other clearances for product code KIT

  • K892938 — AMNIO-GROW TM (May 22, 1989)
  • K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM) (February 24, 1989)
  • K890700 — MELANOCYTE GROWTH MEDIUM (MGM) (February 24, 1989)
  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K883065 — ALLOPREP SYSTEM (October 13, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)

FDA data resources