Atlas FDA

STRAITH CHIN IMPLANTS

FDA 510(k) clearance K801073 · decided 1980-05-20

Clearance details

K-number
K801073
Device name
STRAITH CHIN IMPLANTS
Applicant
Surgical Technology Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1980-05-06
Decision date
1980-05-20
Days to decision
14 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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RecordFirmDate
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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.