Atlas FDA

CHIN (MENTOPLASTY) IMPLANTS

FDA 510(k) clearance K831724 · decided 1983-08-12

Clearance details

K-number
K831724
Device name
CHIN (MENTOPLASTY) IMPLANTS
Applicant
S. Jackson, Inc.
Decision
Substantially Equivalent
Date received
1983-05-31
Decision date
1983-08-12
Days to decision
73 days
Clearance type
Traditional
Product code
FWP
Device class
2
Regulation number
878.3550
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEDPOR Customized Implant Kit (K254233)Stryker Leibinger GmbH & Co KG2026-03-12
FITme Customized Silicone Implant (K232593)Keosan Trading Co.2023-11-22
Customized Contour Implant (K200610)Implantech Associates, Inc.2020-12-23
Customized Contour Implant (K191130)Implantech Associates, Inc.2019-08-23
Stryker CMF MEDPOR Priority Customized Implant Kit (K191916)Stryker Leibinger GmbH & Co KG2019-08-15
Stryker CMF MEDPOR Customized Implant (K153508)Stryker2016-02-05
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (K152463)Poriferous, LLC2016-01-20
Stryker CMF MEDPOR Customized Implant (K143173)Stryker2015-03-23
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP (K141027)Implantech Associates, Inc.2014-07-10
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (K121315)Howmedica Osteonics Corp.2012-11-01
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011)Surgical Technology Laboratories, Inc ("Stl")2009-04-22
AART CHIN IMPLANT (K021417)Aesthetic and Reconstructive Technologies, Inc.2002-07-02

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SUPRAMID EXTRA SUTURES (N80838/S017)S. Jackson, Inc.1990-01-26
SUPRAMID EXTRA SUTURES (N80838/S016)S. Jackson, Inc.1989-10-19
SUPRAMID EXTRA SUTURES (N80838/S014)S. Jackson, Inc.1989-08-02
SUPRAMID EXTRA SUTURES (N80838/S015)S. Jackson, Inc.1989-06-08
SUPRAMID EXTRA SUTURES (N80838/S013)S. Jackson, Inc.1988-08-31
SUPRAMID EXTRA SUTURES (N80838/S012)S. Jackson, Inc.1987-09-09
SUPRAMID EXTRA SUTURES (N80838/S011)S. Jackson, Inc.1987-06-29
SUPRAMID EXTRA SUTURES (N80838/S010)S. Jackson, Inc.1986-08-05