FDA.reportPublic FDA data

510(k) K801952

Device
SPINE ALIGN
Applicant
B.H. Richardson, D.C.
510(k) number
K801952
Product code
KYI
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-16
Date received
1980-08-18
Regulation
888.3770
Classification name
Prosthesis, Wrist, Carpal Trapezium
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K060386NEXA CARPO METACARPAL IMPLANTNexa Orthopedics, Inc.2006-05-10
K052596MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507Biopro, Inc.2005-11-15
K042690ASCENSION PYROSPHERE (PCS)Ascension Orthopedics, Inc.2004-11-13
K040070ARTELON SPACER CMC-1Artimplant AB2004-09-21
K041451ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc.2004-08-25
K033529TIE-IN TRAPEZIUMWrightmedicaltechnologyinc2003-12-03