510(k) K010701
- Device
- MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
- Applicant
- MEDTRONIC SOFAMOR DANEK USA, INC.
- 510(k) number
- K010701
- Product code
- LYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-05
- Date received
- 2001-03-08
- Regulation
- 872.3930
- Classification name
- Bone Grafting Material, Synthetic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RIHCARD W TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3038718579
- 2245304
- 1650372
- 2011171
- 3003775072
- 9610921
- 1221541
- 2032542
- 2081055
- 3027448274
- 3003768919
- 3010162973
- 1223843
- 3015780293
- 3002983930
- 1410097
- 3010160527
- 1030489
- 3002673655
- 1225112
- 8043792
- 3004450973
- 3011649314
- 3004142400
- 3007708799
- 3004847139
- 1450662
- 2024024
- 2249852
- 3004525100
- 1928237
- 3011824442
- 3002807315
- 3002807310
- 3011795235
- 9612300
- 3017036472
- 1319639
- 2024311
- 3007663067
- 2219920
- 3011050570
- 1526439
- 1647149
- 3003418325
- 3004203816
- 3012447612
- 3007490610
- 3006946279
- 3011936113
- 1058584
- 1416980
- 3021912300
- 1037007
- 3002807314
- 1066741
- 9681465
- 2648988
- 3006223010
- 2431866
- 3008114965
- 2029275
- 9612827
- 1319660
- 3009417901
- 3011276344
- 1000194445
- 3003300673
- 3007225376
- 3006540014
- 3004024955
- 3015219237
- 9710629
- 1423662
- 3004464325
- 3003771570
- 1121308
- 2650143
- 3016050940
Source Documents#
Other 510(k) Records For Product Code LYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | 2026-05-14 |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | 2026-03-06 |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | 2025-09-17 |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | 2025-08-29 |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 |
| K213260 | CMFlexTM | Dimension Inx Corp. | 2022-12-30 |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | 2022-03-04 |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | 2020-10-02 |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020-09-24 |
| K192597 | Cytrans Granules | GC America, Inc. | 2020-08-17 |
| K153676 | OSTEON III | Genoss Co., Ltd. | 2016-09-14 |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | 2016-07-14 |
| K140374 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | 2014-06-10 |
| K121177 | BOND APATITE | Augma Biomaterials, Ltd. | 2013-12-05 |
| K131385 | EASY-GRAFT | Degradable Solutions AG | 2013-09-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases