510(k) K190385
- Device
- CoLink Plating System, Fracture And Correction System, RTS Implant System, NeoSpan Compression Staple System
- Applicant
- In2Bones USA, LLC
- 510(k) number
- K190385
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-08-08
- Date received
- 2019-02-19
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christine Scifert
- Address
- 6000 Poplar Ave. Suite 115 Memphis TN US 38119 38119
FDA Registration Numbers#
- 1221051
- 2245304
- 3009923578
- 3010068573
- 3013843055
- 9610921
- 3009662565
- 3011127597
- 3003541440
- 3005562917
- 8010099
- 3010041511
- 3011295718
- 1020279
- 3004369035
- 3009973699
- 3010041430
- 3007420745
- 2030624
- 3009959868
- 3014315669
- 3033519208
- 1313525
- 3027339877
- 3006783837
- 3007289093
- 3014302784
- 3016237080
- 2249615
- 3004142400
- 3009812190
- 3000170817
- 3014937101
- 3022159082
- 1319429
- 1528646
- 3010726901
- 3016778139
- 2531477
- 3004549189
- 3004153896
- 2183785
- 3013756169
- 9680515
- 3007738812
- 1526439
- 3011187779
- 3014273424
- 9611281
- 3017980495
- 3010032903
- 1043653
- 1720929
- 3016247852
- 3008534770
- 3010673777
- 3012491394
- 3013014058
- 3015230955
- 3009158523
- 3005004799
- 3011580264
- 3011354099
- 3004187715
- 1828464
- 1833506
- 1835831
- 3005874553
- 3016759112
- 3007334927
- 3006946279
- 2032830
- 3007125392
- 3010123172
- 3008572101
- 3002579136
- 3019455
- 1818910
- 9614438
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
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