Drill, Hand, Bone, Smedberg
FDA 510(k) K871834 · Military Engineering, Inc.
510(k) numberK871834
Submission
- Device name
- Drill, Hand, Bone, Smedberg
- Applicant
- Military Engineering, Inc.
Plymouth, IN, US - Received
- May 12, 1987
- Decision date
- July 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
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| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874335 | Explorer-Dental ProberEKJ · Traditional | 12/29/1987SE |
| K873715 | Bone Pin Cutter 18HXZ · Traditional | 10/28/1987SE |
| K872842 | Pin, Hip, KnowlesHTY · Traditional | 08/07/1987SE |
| K872091 | Currettes, Alveolar (Molt and Miller)EMS · Traditional | 07/31/1987SE |
| K872738 | Cortical Bone ScrewsHWC · Traditional | 07/30/1987SE |
| K872609 | Curette Set, Antrum, CoakleyKAP · Traditional | 07/15/1987SE |
| K871818 | Spatula, Dental, CementEJB · Traditional | 07/02/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | 06/23/1987SE |
| K870590 | Curette, Periodontal, Columbia UniversityEMS · Traditional | 04/16/1987SE |
| K871195 | Mallet, Bone Surgery, Stainless Steel, 2LB.HXL · Traditional | 04/06/1987SE |
Questions and answers
When was Drill, Hand, Bone, Smedberg cleared by the FDA?
Drill, Hand, Bone, Smedberg (K871834) received a 510(k) decision of Substantially Equivalent on July 31, 1987, 80 days after the submission was received.
What is the product code of K871834?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.