Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits
FDA 510(k) K141219 · Biomet Manufacturing Corp
510(k) numberK141219
Submission
- Device name
- Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- May 12, 2014
- Decision date
- July 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits cleared by the FDA?
Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits (K141219) received a 510(k) decision of Substantially Equivalent on July 18, 2014, 67 days after the submission was received.
What is the product code of K141219?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.