ClearanceBrief
Panels › General, Plastic Surgery › Product code FWP · Class 2

Prosthesis, Chin, Internal

Regulation 878.3550

1510(k)s in 12 months (66 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in FWP

Company510(k)sRecalls
Implantech Associates, Inc.161
Spectrum Designs, Inc.70
Byron Medical40
Stryker Craniomaxillofacial Division03
W. L. Gore & Associates, Inc.30
Applied Biomaterial Technologies20
Cui Corp.20
Omega Silicone, Inc.20
Porex Medical20
Porex Surgical, Inc.20
DateFirm and productCodeLinked 510(k)
Dec 18, 2025DSAART LLC
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B4904001
Open, Classified		 FWPK021417
Feb 11, 2015Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery
Terminated		 FWPK952677
Feb 11, 2015Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosm
Terminated		 FWPK952677
Feb 11, 2015Stryker Craniomaxillofacial Division
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weig
Terminated		 FWPK922489
Sep 17, 2013Implantech Associates Inc
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Terminated		 FWPK902824

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