Atlas FDA

Monterey AL Interbody System

FDA 510(k) clearance K201585 · decided 2020-08-10

Clearance details

K-number
K201585
Device name
Monterey AL Interbody System
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2020-06-11
Decision date
2020-08-10
Days to decision
60 days
Clearance type
Traditional
Product code
OVD
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. recall (Z-1488-2025)Stryker Spine2025-03-31
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. recall (Z-1489-2025)Stryker Spine2025-03-31
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. recall (Z-1490-2025)Stryker Spine2025-03-31
Monterey AL Implant Inserter; 22mm; Catalog 48019140. recall (Z-1491-2025)Stryker Spine2025-03-31

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19