Orthoplug Hard Bone Design
FDA 510(k) K955631 · Sunmed, Inc.
510(k) numberK955631
Submission
- Device name
- Orthoplug Hard Bone Design
- Applicant
- Sunmed, Inc.
Redding, CA, US - Received
- December 11, 1995
- Decision date
- February 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZN – Cement Obturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement RestrictorLZN · Traditional | Howmedica Osteonics, Dba Stryker Orthopaedics | 05/20/2022SE |
| K061824 | Tornier Cement RestrictorLZN · Traditional | Tornier | 09/14/2006SE |
| K032685 | Cemstop Cement RestrictorLZN · Traditional | Teknimed, S.A. | 11/26/2003SE |
| K023680 | Biobuck Cement RestrictorLZN · Special | Smith & Nephew, Inc. | 11/19/2002SE |
| K011943 | Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional | Kensey Nash Corp. | 09/19/2001SE |
| K010840 | SynplugLZN · Special | Isotis NV | 04/20/2001SE |
| K993841 | Cemstop Cement RestrictorLZN · Traditional | Encore Orthopedics, Inc. | 05/04/2000SE |
| K000587 | Shuttle StopLZN · Traditional | Isotis NV | 05/04/2000SE |
| K992462 | Osteonics Universal Distal Cement PlugLZN · Traditional | Howmedica Osteonics Corp. | 08/13/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | Turnkey Intergration USA, Inc. | 08/29/1997SE |
More from Turnkey Intergration USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | 08/02/2024SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | 03/28/2013SE |
| K081805 | CuffalertBSK · Traditional | 11/14/2008SE |
| K062112 | Sunmed Foley CathetersEZL · Traditional | 06/04/2007SE |
| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | 02/27/1996SE |
| K921263 | Sunlite LaryngoscopeCCW · Traditional | 06/01/1993SE |
Questions and answers
When was Orthoplug Hard Bone Design cleared by the FDA?
Orthoplug Hard Bone Design (K955631) received a 510(k) decision of Substantially Equivalent on February 27, 1996, 78 days after the submission was received.
What is the product code of K955631?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.