Atlas FDA

RSP HUMERAL SOCKET INSERT

FDA 510(k) clearance K141006 · decided 2014-06-05

Clearance details

K-number
K141006
Device name
RSP HUMERAL SOCKET INSERT
Applicant
Djo Global
Decision
Substantially Equivalent
Date received
2014-04-18
Decision date
2014-06-05
Days to decision
48 days
Clearance type
Special
Product code
PHX
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
InSet Reverse Total Shoulder System (K254128)Shoulder Innovations, Inc.2026-04-13
Blueprint Patient-Specific Instrumentation (K253674)Stryker Corporation (Tornier, S.A.S.)2026-04-03
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MSS - Monobloc stem (K250644)Medacta International S.A.2026-02-03
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Scandinavian Total Ankle Replacement (STAR) (P050050/S026)Djo Global2024-03-13
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S024)Djo Global2023-11-13
STAR PSI System (P050050/S023)Djo Global2022-11-22
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S025)Djo Global2022-09-29
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S021)Djo Global2022-05-06
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S022)Djo Global2022-03-11
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S020)Djo Global2021-12-17
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S019)Djo Global2021-08-23