Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits
FDA 510(k) K091041 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK091041
Submission
- Device name
- Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Raynham, MA, US - Received
- April 13, 2009
- Decision date
- August 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- 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 Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits cleared by the FDA?
Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits (K091041) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 116 days after the submission was received.
What is the product code of K091041?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.