Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
FDA 510(k) K130814 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK130814
Submission
- Device name
- Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Raynham, MA, US - Received
- March 25, 2013
- Decision date
- August 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K131191 | 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus…HRX · Traditional | 07/22/2013SE |
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Questions and answers
When was Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM cleared by the FDA?
Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM (K130814) received a 510(k) decision of Substantially Equivalent on August 1, 2013, 129 days after the submission was received.
What is the product code of K130814?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.