Pro Osteon 200R with Calcium Sulfate, Models 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
FDA 510(k) K004003 · Interpore Cross Intl.
510(k) numberK004003
Submission
- Device name
- Pro Osteon 200R with Calcium Sulfate, Models 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- December 25, 2000
- Decision date
- July 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K050861 | PEEK CasMQP · Special | 05/27/2005SE |
| K031399 | Intergro DBMMQV · Traditional | 02/18/2005SE |
| K041407 | Titanium Mesh ImplantMQP · Traditional | 12/29/2004SE |
| K043229 | Modification to Altius Oct SystemKWP · Special | 12/21/2004SE |
| K042798 | C-Tek C-Trun Anterior Cervical Plate SystemKWQ · Special | 11/04/2004SE |
| K040928 | Expandable PEEK VBR ImplantMQP · Traditional | 08/27/2004SE |
| K041794 | C-Tek C-Thru Anterior Cervical Plate SystemKWQ · Special | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | 07/01/2004SE |
| K033961 | Altius Oct SystemKWP · Special | 04/14/2004SE |
| K040168 | Modification to Geo StructureMQP · Special | 04/08/2004SE |
Questions and answers
When was Pro Osteon 200R with Calcium Sulfate, Models 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 cleared by the FDA?
Pro Osteon 200R with Calcium Sulfate, Models 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 (K004003) received a 510(k) decision of Substantially Equivalent on July 19, 2001, 206 days after the submission was received.
What is the product code of K004003?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.