Atlas FDA

CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM

FDA 510(k) clearance K050852 · decided 2005-06-22

Clearance details

K-number
K050852
Device name
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
Applicant
I.T.S. Implantat-Technologie-Systeme GmbH
Decision
Substantially Equivalent
Date received
2005-04-04
Decision date
2005-06-22
Days to decision
79 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Prior Lake, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch I.T.S. Implantat-Technologie-Systeme GmbH

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Xpert Ankle (K261511)Newclip Technics2026-07-28
Versalock Proximal Tibial Plating System (K261406)GM Dos Reis Industria e Comercio Ltda.2026-07-21
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (K262032)TriMed, Inc.2026-07-16
Alians Elbow S (K261191)Newclip Technics2026-07-08
RibPlate System (K261054)Stryker Leibinger GmbH & Co KG2026-07-01
SALGINA 2.5mm Distal Radius System (K261351)Bonebridge AG2026-06-26
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (K260958)I.T.S. GmbH2026-06-16
Exalta Proximal Tibia Plating System (K261207)Tyber Medical, LLC2026-06-12
APTUS Clavicle System 2.8 (K260761)Medartis AG2026-06-05
Pectus Blu System (K261002)Biomet Microfixation2026-06-02
Xpert PFP (K261038)Newclip Technics2026-05-29
Avanti Distal Elbow ORIF System (K261145)Avanti Orthopaedics, LLC2026-05-09

Recalls involving this device

RecordFirmDate
Claviculaplate with Angular Stability, with the below descriptions and associated article recall (Z-1593-2026)I.T.S. GmbH2026-03-20