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510(k) K181192

PIP Fix by Hand Biomechanics Lab, Inc. — Product Code JEC

K181192 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "PIP Fix". The FDA issued a decision of Substantially Equivalent on October 22, 2018. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2018
Date Received
May 4, 2018
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 Hand Biomechanics Lab, Inc.

  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K222490 — HBL Blade Assembly (November 14, 2022)
  • K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (January 9, 2008)
  • K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-3 (November 5, 2003)
  • K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, C (June 10, 2003)
  • K992970 — DIGIT WIDGET (November 8, 1999)
  • K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 (February 12, 1999)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)

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)
  • 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)
  • K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (August 24, 2007)

FDA data resources