Implant, Malar

Device Code: 5737

Product Code(s): LZK

Device Classification Information

• Device Type ID: 5737
• Device Name: Implant, Malar
• Regulation Description: Chin Prosthesis.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.3550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LZK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-185 ASTM F881-94 (Reapproved 2014)
  Standard Specification For Silicone Elastomer Facial Implants
• 8-179 ASTM F754-08 (Reapproved 2015)
  Standard Specification For Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, And Rod Shapes Fabricated From Granular Molding Powders

Total Product Life Cycle

• Device Type ID: 5737
• Device: Implant, Malar
• Product Code: LZK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Chin Prosthesis.
• CFR Regulation Number: 878.3550 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	5
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Spectrum Designs Inc	II	Jun-25-2015

TPLC Last Update: 2019-04-02 21:11:41