Home / 510(k) Clearances / K872538

510(k) K872538

VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS by Vitaphore Corp. — Product Code JEC

K872538 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS". The FDA issued a decision of Substantially Equivalent on July 10, 1987. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Vitaphore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1987
Date Received
June 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Vitaphore Corp.

  • K914579 — SILVER FOAM WOUND DRESSING (February 21, 1992)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K895920 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (June 6, 1991)
  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • K891993 — COLLAGEN NEUROSPONGE (March 23, 1990)
  • K896455 — VITACHOICE WOUND DRESSING (February 15, 1990)
  • K896046 — VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE (January 11, 1990)
  • K895993 — VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (January 11, 1990)
  • K890435 — VITAACCESS CATHETER INTRODUCER KIT (March 29, 1989)
  • K882100 — VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT (July 13, 1988)

Other clearances for product code JEC

  • K203605 — SteriTrak (April 23, 2021)
  • K193256 — Anjon Bremer Halo System (March 2, 2020)
  • K192465 — DigiFix Sterile Kit (October 10, 2019)
  • K181192 — PIP Fix (October 22, 2018)
  • K171863 — Anjon Bremer Halo System (March 19, 2018)
  • K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices (December 28, 2016)
  • K132731 — DIGIFIX EXTERNAL FIXATION SYSTEM (January 10, 2014)
  • K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020 (January 14, 2011)
  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
  • K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (January 9, 2008)

FDA data resources