Synplug
FDA 510(k) K010840 · Isotis NV
510(k) numberK010840
Submission
- Device name
- Synplug
- Applicant
- Isotis NV
North Attleboro, MA, US - Received
- March 21, 2001
- Decision date
- April 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCMQV · Traditional | 08/15/2007SE |
| K060332 | Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyNUN · Traditional | 03/29/2006SE |
| K060306 | Accell Connexus Demineralized Bone Matrix PuttyNUN · Traditional | 03/27/2006SE |
| K031813 | Ossatura DentalLYC · Traditional | 08/20/2004SE |
| K041344 | Open Bore SyringeFMF · Abbreviated | 07/16/2004SE |
| K030131 | Ossatura BCP Bone Void FillerMQV · Traditional | 05/20/2003SE |
| K000587 | Shuttle StopLZN · Traditional | 05/04/2000SE |
Questions and answers
When was Synplug cleared by the FDA?
Synplug (K010840) received a 510(k) decision of Substantially Equivalent on April 20, 2001, 30 days after the submission was received.
What is the product code of K010840?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.