Prosthesis, Chin, Internal

Device Code: 5547

Product Code(s): FWP

Device Classification Information

• Device Type ID: 5547
• Device Name: Prosthesis, Chin, Internal
• 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); Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.3550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FWP
• 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: 5547
• Device: Prosthesis, Chin, Internal
• Product Code: FWP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Chin Prosthesis.
• CFR Regulation Number: 878.3550 [🔎]

Premarket Reviews
Manufacturer	Decision
IMPLANTECH ASSOCIATES INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Adverse Event Without Identified Device Or Use Problem	3
Break	1
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Craniomaxillofacial Division	II	Feb-11-2015

TPLC Last Update: 2019-04-02 21:08:16