Prime Femoral Cement Plug
FDA 510(k) K955751 · Orthopaedic Innovations, Inc.
510(k) numberK955751
Submission
- Device name
- Prime Femoral Cement Plug
- Applicant
- Orthopaedic Innovations, Inc.
Minneapolis, MN, US - Received
- December 20, 1995
- Decision date
- January 26, 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 |
|---|---|---|
| K020145 | Orthopaedic Innovations Renewal Acetabular Cup SystemLPH · Traditional | 04/15/2002SE |
| K983881 | Cobra External FixatorHRS · Traditional | 12/04/1998SE |
| K962646 | Prime Modular Endo HeadKWL · Traditional | 09/23/1996SE |
| K960014 | Practifix External Fixation SystemKTT · Traditional | 03/18/1996SE |
| K955620 | Prime Cemented Calcar Femoral StemsJDI · Traditional | 02/20/1996SE |
| K953033 | Prime Cemented Small Femoral StemJDI · Traditional | 09/13/1995SE |
| K940328 | Prime Cemented Hip SystemJDI · Traditional | 04/07/1995SN |
Questions and answers
When was Prime Femoral Cement Plug cleared by the FDA?
Prime Femoral Cement Plug (K955751) received a 510(k) decision of Substantially Equivalent on January 26, 1996, 37 days after the submission was received.
What is the product code of K955751?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.