Fibula Plate Prolock with Angular Stability
FDA 510(k) K063672 · I.T.S. Implantat-Technologie-Systeme GmbH
510(k) numberK063672
Submission
- Device name
- Fibula Plate Prolock with Angular Stability
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
Prior Lake, MN, US - Received
- December 11, 2006
- Decision date
- February 2, 2007
- 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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| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
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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 |
| 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 |
| K050852 | Claviculaplate with Angular Stablity Bone Plate SystemHRS · Traditional | 06/22/2005SE |
Questions and answers
When was Fibula Plate Prolock with Angular Stability cleared by the FDA?
Fibula Plate Prolock with Angular Stability (K063672) received a 510(k) decision of Substantially Equivalent on February 2, 2007, 53 days after the submission was received.
What is the product code of K063672?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.