510(k) K100986
- Device
- CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
- Applicant
- SKELETAL KINETICS, LLC
- 510(k) number
- K100986
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-20
- Date received
- 2010-04-09
- 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
- CHRISTINE KUO
- Address
- 10201 Bubb Rd. Cupertino CA US 95014 95014
FDA Registration Numbers#
- 2029447
- 3008583793
- 3011302692
- 2245304
- 3008812241
- 1225991
- 3009595577
- 3014004349
- 2011171
- 3003775072
- 3010132111
- 9610921
- 9614442
- 3016438694
- 3030412764
- 3027448274
- 3008812173
- 3003477135
- 3003768919
- 3010162973
- 3008868758
- 3008147766
- 3015780293
- 3004146122
- 3004111573
- 3005031160
- 1226544
- 3009905888
- 1054811
- 2027754
- 3006524618
- 3012161787
- 1056553
- 3027339877
- 3002807408
- 2249062
- 1417485
- 3011324393
- 2249915
- 3010160527
- 3009672666
- 3013820501
- 3016592693
- 1030489
- 3002673655
- 3013255153
- 3012495575
- 2031966
- 1225112
- 3000215346
- 8043792
- 3011121816
- 3007093114
- 3004450973
- 3013680140
- 1032347
- 3005819474
- 3004142400
- 3016851379
- 3008773560
- 3004847139
- 3008102042
- 1450662
- 1221763
- 3008514120
- 2031093
- 2024024
- 3010473074
- 3000779542
- 3030991335
- 2249852
- 3010667733
- 3010097171
- 3013176080
- 3002807315
- 3002807310
- 3011795235
- 2030598
- 3004788213
Source Documents#
Other 510(k) Records For Product Code MQV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250346 | BonVie+ | Elute, Inc. | 2025-02-26 |
Legacy Summary#
summary
FDA Review#
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