510(k) K991854
- Device
- OSTEOPLAST, MODEL POP200
- Applicant
- INTERPORE CROSS INTL.
- 510(k) number
- K991854
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-26
- Date received
- 1999-06-01
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN RODARTI
- Address
- 181 Technology Dr. Irvine CA US 92618 92618
FDA Registration Numbers#
- 3006053983
- 3009217531
- 1721676
- 3027339877
- 1824199
- 1226544
- 3007093114
- 9681465
- 3007225376
- 1220246
- 2031966
- 3007738819
- 3034676720
- 3010667733
- 1416980
- 3038284487
- 3019403037
- 1225112
- 9614442
- 3005819474
- 3010376334
- 3008559295
- 3021226419
- 3015724777
- 3012329552
- 3003477135
- 3025603301
- 3004774118
- 3016592693
- 3033809758
- 3012447612
- 1526534
- 3005652161
- 3003828812
- 3011964577
- 3008812241
- 3013255153
- 9615021
- 3002808022
- 3014211822
- 3005304945
- 3011121816
- 8030965
- 3015946784
- 1032347
- 9610921
- 3005031160
- 3012495575
- 3003771570
- 3011483489
- 3012448339
- 3005064037
- 2647346
- 3011415547
- 3002807314
- 9615788
- 3010132111
- 3009882464
- 1047843
- 3013491327
- 3004464325
- 2530154
- 3006524618
- 3010120148
- 3018094310
- 3009905888
- 3009417901
- 1221763
- 2027062
- 3004146122
- 3005972619
- 3008328709
- 3010473074
- 3014387294
- 2246552
- 3008812251
- 1054811
- 2245304
- 3008110533
- 3008147766
Source Documents#
Other 510(k) Records For Product Code MQV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260364 | Device 300419 Strip | Geistlich Pharma AG | 2026-06-02 |
| K252797 | JAZBI™ Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | 2026-05-26 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | Stryker Spine | 2026-04-24 |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | 2026-02-17 |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2025-10-22 |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2025-10-13 |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-09-30 |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | 2025-07-17 |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-07-02 |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-05-28 |
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025-05-23 |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | 2025-05-16 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | 2025-04-07 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 2025-03-21 |
Legacy Summary#
summary
FDA Review#
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