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510(k) K120220

ADAPTAIN SOLUBLE IMPLANT MATERIAL by Ceremed , Inc. — Product Code KHJ

K120220 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "ADAPTAIN SOLUBLE IMPLANT MATERIAL". The FDA issued a decision of Substantially Equivalent on June 6, 2012. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Ceremed , Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
January 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Ceremed , Inc.

  • K161446 — Biopor Porous Polyethylene Implants (September 27, 2016)
  • K160988 — Biopor, AOC Porous Polyethylene, Cerepor (July 14, 2016)
  • K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (April 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K102071 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (October 8, 2010)
  • K091636 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (June 22, 2009)
  • K082491 — OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTE (September 24, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K161000 — Biodesign Otologic Repair Graft (May 11, 2016)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)
  • K081531 — AOC SOLUBLE IMPLANT MATERIAL (July 18, 2008)

FDA data resources