Silastic Inflatable Bone Plug H.P.
FDA 510(k) K853186 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK853186
Submission
- Device name
- Silastic Inflatable Bone Plug H.P.
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Hemlock, MI, US - Received
- July 30, 1985
- Decision date
- September 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K844637 | Whiteside Acrylic Cement Spacer SleeveLTC · Traditional | 06/19/1985SE |
| K850255 | Dow Corning Wright Titanium Wrist Joint Grommet · Traditional | 05/01/1985SE |
| K843995 | Tf-Ii Hip ProsthesisKWL · Traditional | 04/23/1985SE |
| K842559 | Whiteside Ortholoc Total Hip FemoralKWL · Traditional | 12/20/1984SE |
| K840357 | Ssa Hip ProsthesisJDI · Traditional | 02/17/1984SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | 07/10/1981SE |
| K801175 | Silastic II Mammary Implant · Traditional | 12/18/1980SE |
Questions and answers
When was Silastic Inflatable Bone Plug H.P. cleared by the FDA?
Silastic Inflatable Bone Plug H.P. (K853186) received a 510(k) decision of Substantially Equivalent on September 24, 1985, 56 days after the submission was received.
What is the product code of K853186?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.