510(k) K833865
- Device
- ACE BROOKER BONE PLATING SYSTEM
- Applicant
- BUCKMAN CO., INC.
- 510(k) number
- K833865
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-12-12
- Date received
- 1983-11-07
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Clearance type
- Traditional
- Third party reviewed
- No
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|---|---|---|---|
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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 |
| 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 |
Legacy Summary#
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FDA Review#
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