Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
FDA 510(k) K980817 · Interpore Intl.
510(k) numberK980817
Submission
- Device name
- Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
- Applicant
- Interpore Intl.
Irvine, CA, US - Received
- March 3, 1998
- Decision date
- September 25, 1998
- 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 |
|---|---|---|
| K981253 | Ultracon UltrafiltratorFJI · Traditional | 12/11/1998SE |
| K972842 | Interpore Inducer Bone Graft Delivery SyringeLYC · Traditional | 10/30/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | 06/03/1997SE |
| K960945 | Imz Membrane Tack SystemDZL · Traditional | 05/24/1996SE |
| K960371 | Interpore Threaded ImplantDZE · Traditional | 03/08/1996SE |
| K955492 | Interpore Imz Cyl Implant & Cyl Hex ImpltDZE · Traditional | 01/30/1996SE |
| K952167 | Imz Bone Tack SystemDZL · Traditional | 11/21/1995SE |
| K950165 | Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000…LYC · Traditional | 03/28/1995SE |
| K922872 | Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 MM Diam.DZE · Traditional | 07/25/1994SE |
| K922732 | Interpore Cylindrical Hex Implant, 3.3 MM DiameterDZE · Traditional | 02/10/1994SE |
Questions and answers
When was Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L cleared by the FDA?
Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L (K980817) received a 510(k) decision of Substantially Equivalent on September 25, 1998, 206 days after the submission was received.
What is the product code of K980817?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.