Atlas FDA

UCLA SHOULDER

FDA 510(k) clearance K801970 · decided 1980-12-31

Clearance details

K-number
K801970
Device name
UCLA SHOULDER
Applicant
Howmedica Corp.
Decision
Substantially Equivalent
Date received
1980-08-19
Decision date
1980-12-31
Days to decision
134 days
Clearance type
Traditional
Product code
KWS
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tornier Perform Advanced Glenoid (K260721)Tornier, Inc.2026-07-22
AETOS Shoulder System - CONCELOC Glenoids (K254084)Smith & Nephew, Inc.2026-04-06
Catalyst F1x Shoulder System (K252418)Catalyst Orthoscience, Inc.2025-11-06
AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416)Smith & Nephew, Inc.2025-10-29
MyShoulder Planner (5.3SSWPL) (K241292)Medacta International S.A.2025-01-30
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878)Stryker Corporation (Tornier, Inc.)2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS) (K241609)Stryker Corporation (Tornier, Inc.)2024-09-10
Arthrex Univers Apex OptiFit Humeral Stem (K230513)Arthrex, Inc.2023-09-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
Catalyst EA Convertible Stemmed Shoulder (K222317)Catalyst Orthoscience, Inc.2022-11-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SURGICAL SIMPLEX P BONE CEMENT (N17004/S013)Howmedica Corp.2000-12-15
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012)Howmedica Corp.2000-06-20
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011)Howmedica Corp.1998-03-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010)Howmedica Corp.1997-11-13
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009)Howmedica Corp.1997-08-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008)Howmedica Corp.1996-12-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005)Howmedica Corp.1995-11-21
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006)Howmedica Corp.1995-02-24