Cementek LV
FDA 510(k) K042911 · Teknimed, S.A.
510(k) numberK042911
Submission
- Device name
- Cementek LV
- Applicant
- Teknimed, S.A.
Round Rock, TX, US - Received
- October 21, 2004
- Decision date
- December 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K103433 | F20NDN · Special | 01/03/2011SE |
| K090435 | VertecemNDN · Special | 12/21/2009SE |
| K083005 | NangelLYC · Traditional | 03/04/2009SE |
| K080873 | Opacity + Bone CementNDN · Special | 08/28/2008SE |
| K062102 | OdoncerLYC · Traditional | 04/16/2007SE |
| K043593 | Spine-Fix Biomimetic Bone CementNDN · Traditional | 03/17/2006SE |
| K041493 | CementekMQV · Traditional | 08/19/2004SE |
| K040669 | Ceraform Bone Void FillerMQV · Special | 05/03/2004SE |
| K031826 | Triha +MQV · Traditional | 11/28/2003SE |
| K032685 | Cemstop Cement RestrictorLZN · Traditional | 11/26/2003SE |
Questions and answers
When was Cementek LV cleared by the FDA?
Cementek LV (K042911) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 67 days after the submission was received.
What is the product code of K042911?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.