Claviculaplate with Angular Stablity Bone Plate System
FDA 510(k) K050852 · I.T.S. Implantat-Technologie-Systeme GmbH
510(k) numberK050852
Submission
- Device name
- Claviculaplate with Angular Stablity Bone Plate System
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
Prior Lake, MN, US - Received
- April 4, 2005
- Decision date
- June 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K093868 | I.T.S. LRS Locking Reconstruction SystemHRS · Traditional | 08/05/2010SE |
| K080706 | Connexx Locking Tibia NailJDS · Traditional | 06/09/2008SE |
| K080184 | Distal Humeral Plates with Angular StabilityHRS · Traditional | 03/26/2008SE |
| K063672 | Fibula Plate Prolock with Angular StabilityHRS · Traditional | 02/02/2007SE |
| K063166 | I.T.S. Pelvic Reconstruction SystemHRS · Traditional | 12/22/2006SE |
| K060156 | Straight Plate with Angular Stability & Screw SystemHRS · Traditional | 03/20/2006SE |
| K052368 | Olecranonplate with Angular StabilityHRS · Traditional | 10/17/2005SE |
| K051642 | Fr.O.H. Calcaneus Repair SystemNDF · Traditional | 08/22/2005SE |
| K052011 | Pilonplate with Angular StabilityHRS · Traditional | 08/10/2005SE |
| K051412 | Humeral Head Plate with Angular StabilityHRS · Traditional | 07/11/2005SE |
Questions and answers
When was Claviculaplate with Angular Stablity Bone Plate System cleared by the FDA?
Claviculaplate with Angular Stablity Bone Plate System (K050852) received a 510(k) decision of Substantially Equivalent on June 22, 2005, 79 days after the submission was received.
What is the product code of K050852?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.