Osferion
FDA 510(k) K061499 · Olympus America, Inc.
510(k) numberK061499
Submission
- Device name
- Osferion
- Applicant
- Olympus America, Inc.
Center Valley, PA, US - Received
- May 31, 2006
- Decision date
- January 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
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| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
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| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
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| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
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Questions and answers
When was Osferion cleared by the FDA?
Osferion (K061499) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 240 days after the submission was received.
What is the product code of K061499?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.