Cemstop Cement Restrictor
FDA 510(k) K032685 · Teknimed, S.A.
510(k) numberK032685
Submission
- Device name
- Cemstop Cement Restrictor
- Applicant
- Teknimed, S.A.
Round Rock, TX, US - Received
- August 29, 2003
- Decision date
- November 26, 2003
- 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 |
| 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 |
| K970779 | Osteonics Tibial Tray Screw Hole PlugsLZN · Traditional | Osteonics Corp. | 05/09/1997SE |
More from Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K103433 | F20NDN · Special | 01/03/2011SE |
| K090435 | VertecemNDN · Special | 12/21/2009SE |
| K083005 | NangelLYC · Traditional | 03/04/2009SE |
| K080873 | Opacity + Bone CementNDN · Special | 08/28/2008SE |
| K062102 | OdoncerLYC · Traditional | 04/16/2007SE |
| K043593 | Spine-Fix Biomimetic Bone CementNDN · Traditional | 03/17/2006SE |
| K042911 | Cementek LVMQV · Special | 12/27/2004SE |
| K041493 | CementekMQV · Traditional | 08/19/2004SE |
| K040669 | Ceraform Bone Void FillerMQV · Special | 05/03/2004SE |
| K031826 | Triha +MQV · Traditional | 11/28/2003SE |
Questions and answers
When was Cemstop Cement Restrictor cleared by the FDA?
Cemstop Cement Restrictor (K032685) received a 510(k) decision of Substantially Equivalent on November 26, 2003, 89 days after the submission was received.
What is the product code of K032685?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.