510(k) K141841
- Device
- INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
- Applicant
- INTEGRA LIFESCIENCE CORPORTATION
- 510(k) number
- K141841
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-01
- Date received
- 2014-07-08
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICOLE C HARLAN
- Address
- 311 Enterprise Dr. Planisboro NJ US 08536 08536
FDA Registration Numbers#
- 1833920
- 3015231789
- 3002673655
- 1030489
- 3002808022
- 3009144915
- 3012448339
- 3008132398
- 3002636527
- 1000194445
- 1319660
- 1047843
- 3008147766
- 2530154
- 9610726
- 2531321
- 3027448274
- 3012495575
- 3010160527
- 1216032
- 3035366890
- 1226544
- 3009417901
- 3002807314
- 3008868758
- 3009217531
- 9614442
- 3011415547
- 3014545238
- 3009595577
- 3013680140
- 2031093
- 1319639
- 3002719998
- 3007738819
- 1721676
- 3038284487
- 9681465
- 3015219237
- 3000270450
- 2246552
- 3006788678
- 3008114965
- 1054811
- 3004024955
- 2027062
- 3005381997
- 3011662387
- 3011964577
- 2090010
- 1417485
- 3003300673
- 3014387294
- 2531195
- 3010162973
- 3009672666
- 3014004349
- 3002807315
- 3011324393
- 3006121828
- 3012329552
- 1645368
- 9615788
- 9617083
- 1066368
- 3009882464
- 3031563325
- 1423662
- 3010770940
- 3004788213
- 1056553
- 2032098
- 3010560653
- 3006404071
- 9610921
- 2011171
- 8030965
- 3003455467
- 3012447612
- 3000215346
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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