MECTALIF

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Mectalif.

Pre-market Notification Details

• Device ID: K110927
• 510k Number: K110927
• Device Name: MECTALIF
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-28
• Decision Date: 2011-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030827563	K110927	000
07630030827389	K110927	000
07630030827372	K110927	000
07630030827365	K110927	000
07630030827358	K110927	000
07630030827341	K110927	000
07630030827334	K110927	000
07630030827327	K110927	000
07630030827310	K110927	000
07630030827303	K110927	000
07630030827297	K110927	000
07630030827280	K110927	000
07630030827273	K110927	000
07630030827266	K110927	000
07630030827259	K110927	000
07630030827396	K110927	000
07630030827402	K110927	000
07630030827419	K110927	000
07630030827556	K110927	000
07630030827549	K110927	000
07630030827532	K110927	000
07630030827525	K110927	000
07630030827518	K110927	000
07630030827501	K110927	000
07630030827495	K110927	000
07630030827488	K110927	000
07630030827471	K110927	000
07630030827464	K110927	000
07630030827457	K110927	000
07630030827440	K110927	000
07630030827433	K110927	000
07630030827426	K110927	000
07630030827242	K110927	000