510(k) K232394
- Device
- Internal Locking Plate and Screw Fixation System
- Applicant
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
- 510(k) number
- K232394
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-15
- Date received
- 2023-08-09
- 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
- Jing Huang
- Address
- # 12, Jinfeng Rd., W. Taihu Science And Technology Industrial Park Changzhou CN 213149 213149
FDA Registration Numbers#
- 3010667733
- 3014314623
- 2183946
- 3007791110
- 3012478585
- 3021635140
- 9610905
- 3010440433
- 3025603301
- 3006272282
- 3008812251
- 9611274
- 3013561205
- 3009996260
- 2245304
- 3016655171
- 9615766
- 3011500362
- 1833506
- 3004983210
- 1226425
- 3009201148
- 9615800
- 3012329552
- 3010673850
- 9611112
- 3002807295
- 3010362364
- 1051526
- 1058084
- 3012491394
- 3006498370
- 3012329926
- 3008236846
- 3016084569
- 3013365802
- 3010502940
- 3022159082
- 3022142628
- 3003661942
- 9610612
- 3007913880
- 1060840
- 3011230048
- 1835831
- 3009662565
- 1221051
- 3016112537
- 3002949614
- 3015882686
- 3006639944
- 3011137372
- 3015231789
- 1000517406
- 3014128887
- 3035785605
- 3012755988
- 3021336182
- 3011127597
- 1649390
- 3031261833
- 1319660
- 1643264
- 3018077525
- 3006791286
- 3006179046
- 3014302784
- 3010047454
- 2028632
- 3007923096
- 9611278
- 3006513362
- 3010470577
- 3004188066
- 3011015572
- 1833824
- 3036756245
- 1226544
- 3015410662
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | 2026-06-16 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| 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 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 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 |