Orthosorb(Tm) Absorbable Cement Restrictor
FDA 510(k) K932595 · Johnson & Johnson Orthopaedics, Inc.
510(k) numberK932595
Submission
- Device name
- Orthosorb(Tm) Absorbable Cement Restrictor
- Applicant
- Johnson & Johnson Orthopaedics, Inc.
Raynham, MA, US - Received
- May 28, 1993
- Decision date
- September 20, 1994
- 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 |
|---|---|---|
| K931466 | PFC Modular Total Knee System, Porous Coated SacriJWH · Traditional | 12/06/1994SE |
| K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentLZO · Traditional | 10/06/1994SE |
| K940190 | Ultima Unipolar Modular HeadKWL · Traditional | 09/29/1994SE |
| K933275 | P.F.C. Ceramic Hip HeadLZO · Traditional | 09/28/1994SE |
| K931655 | P.F.C. Bipolar Hip SystemKWY · Traditional | 06/09/1994SE |
| K933867 | Universal Inset PatellaJWH · Traditional | 06/06/1994SN |
| K935262 | P.F.C. Total Knee System Oval PatellaJWH · Traditional | 06/03/1994SN |
| K931189 | P.F.C. Total Hip System Porous Coated Modular AcetLZO · Traditional | 02/09/1994SE |
| K931054 | Trick Modular Knee Tibial Tray-PorousJWH · Traditional | 01/25/1994SE |
| K924340 | P.F.C. Mod Total Knee/Condyl 3 Fem Comp Tib InsertJWH · Traditional | 01/25/1994SE |
Questions and answers
When was Orthosorb(Tm) Absorbable Cement Restrictor cleared by the FDA?
Orthosorb(Tm) Absorbable Cement Restrictor (K932595) received a 510(k) decision of Substantially Equivalent on September 20, 1994, 480 days after the submission was received.
What is the product code of K932595?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.