510(k) K000515
- Device
- PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
- Applicant
- INTERPORE CROSS INTL.
- 510(k) number
- K000515
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-15
- Date received
- 2000-02-16
- 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
- PROSIE REY-FESSLER
- Address
- 181 Technology Dr. Irvine CA US 92618 92618
FDA Registration Numbers#
- 3018085307
- 3010667733
- 3013491327
- 3003828812
- 3003300673
- 1720929
- 3034676720
- 1645368
- 3011662387
- 1066368
- 3006524618
- 3025603301
- 3008812251
- 2022435
- 1043534
- 1220477
- 2245304
- 3008132398
- 3014004349
- 3002719998
- 2249062
- 1000577893
- 3011795235
- 3008114965
- 3015724777
- 3021226419
- 1220246
- 1047843
- 3010197239
- 3003775072
- 3010258202
- 3010770940
- 3016592693
- 3000215346
- 3012329552
- 1038671
- 3010400367
- 3005972619
- 3008812241
- 1720734
- 3004024955
- 3011683674
- 2246552
- 3010120148
- 3008328709
- 3016851379
- 2650143
- 3003455467
- 3006404071
- 3009756327
- 3002807408
- 9710629
- 9610612
- 3018094310
- 3007699035
- 3027339877
- 3009882464
- 3004549189
- 3031563325
- 3005381997
- 2531321
- 2030598
- 1032347
- 3007738819
- 3012448339
- 3015231789
- 3015780293
- 3019403037
- 1222747
- 1416980
- 3008650117
- 3013282271
- 9617083
- 3014078231
- 1054811
- 3007225376
- 1319660
- 3009144915
- 2531195
- 1225112
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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