510(k) K251296
- Device
- The Acumed Wrist Fixation System
- Applicant
- Acumed, LLC
- 510(k) number
- K251296
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-18
- Date received
- 2025-04-25
- 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
- N
Applicant Contact#
- Contact
- Marina Bull
- Address
- 5885 NE Cornelius Pass Rd. Hillsboro OR US 97124 97124
FDA Registration Numbers#
- 3014273424
- 2029447
- 3010673777
- 3006981798
- 3014763043
- 3013756169
- 3013194153
- 3016655171
- 3011354099
- 9610622
- 3013700547
- 3010287737
- 2320767
- 3010400367
- 3010047454
- 3032588003
- 9613910
- 1421101
- 3038503572
- 1043653
- 3009540749
- 3008868758
- 2028632
- 2245304
- 2183967
- 9611278
- 3026035863
- 3010097171
- 3011301313
- 3017980266
- 3009756327
- 1032347
- 3000170817
- 1220477
- 3011530718
- 3009888740
- 3003761012
- 3010047402
- 9611274
- 3015410662
- 8031010
- 3017528621
- 3016261131
- 3006272282
- 3009417901
- 3021010222
- 3011580264
- 3017191784
- 3015831087
- 3011230048
- 1822565
- 3010536692
- 9710312
- 3002993234
- 3013413393
- 3008572101
- 3004187715
- 3006694268
- 1527105
- 3005751028
- 1835831
- 1935627
- 2134285
- 1828464
- 3004513872
- 3002807310
- 3006801265
- 1834331
- 3011388423
- 1054811
- 3009941480
- 3018077525
- 1030489
- 1424263
- 3019807891
- 3008102042
- 3015531529
- 3008236846
- 3012818475
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
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| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
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| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 |
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| 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 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 |