510(k) K982663
- Device
- STIMULAN- CALCIUM SULFATE BONE VOID FILLER
- Applicant
- ENCORE ORTHOPEDICS, INC.
- 510(k) number
- K982663
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-26
- Date received
- 1998-07-30
- 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
- DEBBIE DE LOS SANTOS
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3009882464
- 3014078231
- 3004142400
- 3008812560
- 2249915
- 3016050940
- 2027062
- 3013680140
- 3013820501
- 3003300673
- 3009595577
- 2249852
- 2249062
- 3008868758
- 3011795235
- 3004788213
- 3003455467
- 1221763
- 1825034
- 3003775072
- 1423662
- 1450662
- 1225991
- 3010275504
- 1645368
- 3010132111
- 3015946784
- 3015724777
- 9615021
- 3007699035
- 3031563325
- 3036756245
- 3008559295
- 3009756327
- 3008583793
- 3005819474
- 3018085307
- 3012329552
- 3043620406
- 1824199
- 3012161787
- 3005381997
- 3011415547
- 1720929
- 3021015512
- 3025603301
- 3011483489
- 1000194445
- 1225112
- 1721676
- 3021988499
- 3004450973
- 3009672666
- 3007193505
- 3003768919
- 3014387294
- 3002808022
- 3002807314
- 3035366890
- 3015219237
- 2032098
- 3018094310
- 1056553
- 3010560653
- 3008514120
- 1032347
- 3002807408
- 1226544
- 3006121828
- 3011662387
- 2090010
- 3008812241
- 1047843
- 3008147766
- 3011302692
- 3012495575
- 2245304
- 1526439
- 2650143
- 3006017180
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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