Home / 510(k) Clearances / K770900

510(k) K770900

CAST BRWM, FRACTURE by Chase Mfg. Co. — Product Code ITM

K770900 is an FDA 510(k) premarket notification submitted by Chase Mfg. Co. for the device "CAST BRWM, FRACTURE". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code ITM (Cage, Knee), a Class I device regulated under 21 CFR 890.3475. Chase Mfg. Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cage, Knee
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Chase Mfg. Co.

  • K791513 — ADAMCO DUST COVER (October 11, 1979)
  • K790993 — INSTANT HOT & COLD PACKS (September 7, 1979)
  • K790644 — SUBMAX (April 26, 1979)
  • K780033 — MATTRESSES, CONDUCTIVE & COVERS (February 21, 1978)
  • K771792 — ENEMA SET (October 20, 1977)
  • K771791 — NEEDLE COUNTING (October 4, 1977)
  • K770898 — FRACTURE CAST BRACE KIT, PLASTIC (July 21, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)

Other clearances for product code ITM

  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K812064 — POLI-AXIAL KNEE CAGE (August 13, 1981)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K760573 — IMPROVED KNEE DRESSING (October 5, 1976)

FDA data resources