Atlas FDA

GLENOID RESURFACE COMPONENT PMN 3M

FDA 510(k) clearance K831234 · decided 1983-06-02

Clearance details

K-number
K831234
Device name
GLENOID RESURFACE COMPONENT PMN 3M
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1983-04-15
Decision date
1983-06-02
Days to decision
48 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
White City, OR, US
Third-party review
No
Expedited review
No

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AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
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TiN Coated Humeral Head (K191698)Fx Shoulder USA, Inc.2020-07-16
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22