Osstaple, Ossplate, Ossforce
FDA 510(k) K061385 · Biomedical Enterprises, Inc.
510(k) numberK061385
Submission
- Device name
- Osstaple, Ossplate, Ossforce
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- May 18, 2006
- Decision date
- May 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
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More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153573 | ConvergeHRS · Traditional | 08/11/2016SE |
| K150125 | Elite Nitinol Fixation SystemJDR · Traditional | 05/11/2015SE |
| K143023 | Nitinol Compression Plating SystemHRS · Traditional | 01/16/2015SE |
| K142292 | Speed, Speed Shift, Speed Titan, Speed ArcJDR · Traditional | 11/17/2014SE |
| K133270 | Speed ArcJDR · Traditional | 04/17/2014SE |
| K133520 | Hammerlock 2HTY · Traditional | 01/09/2014SE |
| K124022 | Speed ShiftJDR · Traditional | 05/14/2013SE |
| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
| K023486 | Osstaple, MaxillofacialJEY · Special | 10/31/2002SE |
Questions and answers
When was Osstaple, Ossplate, Ossforce cleared by the FDA?
Osstaple, Ossplate, Ossforce (K061385) received a 510(k) decision of Substantially Equivalent on May 30, 2007, 377 days after the submission was received.
What is the product code of K061385?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.