Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System
FDA 510(k) K946165 · Elekta Instruments, Inc.
510(k) numberK946165
Submission
- Device name
- Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System
- Applicant
- Elekta Instruments, Inc.
Atlanta, GA, US - Received
- December 19, 1994
- Decision date
- May 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System cleared by the FDA?
Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System (K946165) received a 510(k) decision of Substantially Equivalent on May 23, 1995, 155 days after the submission was received.
What is the product code of K946165?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.