Biostop G Bone Cement Restrictor
FDA 510(k) K943727 · Landos, Inc.
510(k) numberK943727
Submission
- Device name
- Biostop G Bone Cement Restrictor
- Applicant
- Landos, Inc.
Malvern, PA, US - Received
- August 2, 1994
- Decision date
- May 11, 1995
- 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 |
|---|---|---|
| K964226 | Memory Staple (20 Sizes Available)JDR · Traditional | 08/05/1997SE |
| K971070 | Scarf Thread-Head (TM) Head ScrewHWC · Traditional | 07/09/1997SE |
| K971069 | Twist-Off (TM) ScrewHWC · Traditional | 07/09/1997SE |
| K971068 | 34MM Scarf Thread-Head(Tm) ScrewHWC · Traditional | 07/09/1997SE |
| K961732 | KarMEH · Traditional | 07/08/1997SE |
| K970846 | 22.2/+4MM Co CR & Zirconia Femoral HeadLZO · Traditional | 06/05/1997SN |
| K953111 | CorailLZO · Traditional | 12/27/1996SE |
| K962233 | Twist-Off ScrewHWC · Traditional | 10/03/1996SE |
| K962236 | Scarf Thread-Head ScrewHWC · Traditional | 09/20/1996SE |
| K960642 | Nancy NailHTY · Traditional | 05/17/1996SE |
Questions and answers
When was Biostop G Bone Cement Restrictor cleared by the FDA?
Biostop G Bone Cement Restrictor (K943727) received a 510(k) decision of Substantially Equivalent on May 11, 1995, 282 days after the submission was received.
What is the product code of K943727?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.