510(k) K231716

Device: OsteoFlo® HydroPutty?
Applicant: SurGenTec, LLC
510(k) number: K231716
Product code: MQV
Decision: Substantially Equivalent (SESE)
Decision date: 2023-10-02
Date received: 2023-06-13
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

Related Records

Applicant Contact

Contact: Travis Greenhalgh
Address: 911 Clint Moore Rd. Boca Raton FL US 33487 33487

FDA Registration Numbers

3002807408
3007738819
3004549189
3011483489
1000577893
3027448274
2249062
3008773560
2029275
2024024
3031563325
3005064037
3009882464
2029447
1056553
1066368
9610612
3008522639
3008650117
9615021
3008812241
1423662
3004450973
3011121816
3004146122
3002807314
3030991335
3016851379
3003300673
3006121828
3033509898
1000307092
3006788678
3010400367
3008110533
3015542130
3014545238
3021988499
3014004349
3010202439
1047843
3018094310
2011171
3007699035
3009973505
3010331645
1319639
3011324393
2530154
3008868758
1225991
2245304
3013255153
1720734
3010097171
3013491327
2031966
3009756327
3009144915
3012161787
3010560653
1032347
9617083
3014560508
9710629
3010120148
3014982332
8043792
3009595577
1526439
3004024955
2531195
1220477
3027339877
3015231789
3008812560
3008583793
3004847139
3015780293

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MQV

510(k)	Device	Applicant	Decision date
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
K241555	Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	Rti Surgical, Inc.	2025-02-21