510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K112862Substantially Equivalent

Mecta-C

Medacta International SA, Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112862 is the FDA 510(k) clearance record for MECTA-C, a class II device, cleared for Medacta International on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 205 510(k) clearances for Medacta International, from to . As of , FDA records show no recalls naming K112862.

Clearance record

Decision date
Received
(80 days to decision)
Product code
ODP Intervertebral Fusion Device With Bone Graft, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Medacta International 4725 Calle Quetzal Unit B, Camarillo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODP

Trailing 12 months
21 clearances under product code ODP in the twelve months to November 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code ODP, trailing twelve months
MonthClearances
December 20252
January 20265
February 20261
March 20262
April 20264
May 20262
June 20260
July 20263
August 20262
September 20260
October 20260
November 20260