Mecta-C

510(k) Number

K112862 ↗

FDA product code

ODP

Device class

Class II

Regulation

21 CFR Part 888.3080

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

• Versafitcup Cc Trio

  Class II

  FDA 510(k) K103352 Active Cleared 11 Feb 2011

• Mectalif

  Class II

  FDA 510(k) K131671 Active Cleared 5 Jul 2013

• Meta-C Cervical Plate

  Class II

  FDA 510(k) K140361 Active Cleared 12 Jun 2014

• Gmk Sphere

  Class II

  FDA 510(k) K121416 Active Cleared 20 Jul 2012

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