FDA.reportPublic FDA data

510(k) K061498

Device
ALLOFIX ANCHOR, 5.0 MM ANCHOR
Applicant
Musculoskeletal Transplant Foundation
510(k) number
K061498
Product code
JDW
Decision
Substantially Equivalent (SESE)
Decision date
2006-07-06
Date received
2006-05-31
Regulation
888.3040
Classification name
Pin, Fixation, Threaded
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NANCY L BENNEWITZ
Address
125 May St. Edison NJ US 08837 08837

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K211508Steinmann Pins and Kirschner WiresStryker GmbH2021-10-05
K210784Extended HA Half PinsSmith & Nephew, Inc.2021-04-02
K200933Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation2020-05-05
K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd.2020-04-14
K192768Temporary Fixation PinsEisertech, LLC2019-12-26
K182171SMV Scientific K-Wire and PinsSummit Medventures2018-10-25
K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.2017-02-13
K150661ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteCitieffe S.R.L.2015-07-07
K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESVilex, Inc.2014-07-23
K140875OPTOSSOL COMPRESSION DEVICE SYSTEMGenossis, LLC2014-05-30