Biofix* Biodegradable Fixation Rod

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K890902 ↗

FDA Product Code

HTY

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Multiclip Disp. Ligating Clip Device

  Class II

  FDA 510(k) K820999 Active Cleared 13 May 1982

• Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central

  Class II

  FDA 510(k) K974015 Active Cleared 18 May 1998

• Dexon 's' Polyglycolic Acid Mesh

  Class II

  FDA 510(k) K830889 Active Cleared 9 May 1983

• Polyethylene Terephthalate (Pet) Pledget

  Class II

  FDA 510(k) K953425 Active Cleared 21 Aug 1995

• Davis & Geck Needle/Sharps Counter

  Class I

  FDA 510(k) K811191 Active Cleared 27 May 1981

• Valtrac (Bar) Remover Device

  Class I

  FDA 510(k) K863752 Active Cleared 24 Oct 1986

See all devices from Davis & Geck, Inc. →