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510(k) K140414

IMBIBE NEEDLE by Orthovita, Inc. — Product Code LXH

K140414 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "IMBIBE NEEDLE". The FDA issued a decision of Substantially Equivalent on April 1, 2014. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Orthovita, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2014
Date Received
February 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Orthovita, Inc.

  • K163621 — Vitoss Bioactive (BA) Injectable (May 2, 2017)
  • K161447 — HydroSet XT (October 6, 2016)
  • K153608 — Vitoss BiModal Bone Graft Substitute Foam Strip (February 12, 2016)
  • K153306 — Imbibe Needle (December 18, 2015)
  • K140868 — STRYKER KWIC NEEDLE (June 5, 2014)
  • K103173 — VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE (February 7, 2011)
  • K101171 — ORTHOVITA PEEK SPACER (January 25, 2011)
  • K102545 — FM-02 BONE GRAFT SUBSTITUTE (October 27, 2010)
  • K091618 — VITOMATRIX (September 27, 2010)
  • K080108 — CORTOSS BONE AUGMENTATION MATERIAL (June 5, 2009)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)
  • K933772 — PUNCH SURGICAL (February 1, 1994)

FDA data resources