Atlas FDA

SPINE ALIGN

FDA 510(k) clearance K801952 · decided 1980-09-16

Clearance details

K-number
K801952
Device name
SPINE ALIGN
Applicant
B.H. Richardson, D.C.
Decision
Substantially Equivalent
Date received
1980-08-18
Decision date
1980-09-16
Days to decision
29 days
Clearance type
Traditional
Product code
KYI
Device class
2
Regulation number
888.3770
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
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MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089)Biopro, Inc.2006-06-20
NEXA CARPO METACARPAL IMPLANT (K060386)Nexa Orthopedics, Inc.2006-05-10
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (K052596)Biopro, Inc.2005-11-15
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Recalls involving this device

No recalls on record reference this clearance.