Depuy Motech Peak Polyaxial Anterior Cervical Plate System
FDA 510(k) K971730 · Depuy, Inc.
510(k) numberK971730
Submission
- Device name
- Depuy Motech Peak Polyaxial Anterior Cervical Plate System
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- May 9, 1997
- Decision date
- November 3, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
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Questions and answers
When was Depuy Motech Peak Polyaxial Anterior Cervical Plate System cleared by the FDA?
Depuy Motech Peak Polyaxial Anterior Cervical Plate System (K971730) received a 510(k) decision of Substantially Equivalent for Some Indications on November 3, 1997, 178 days after the submission was received.
What is the product code of K971730?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.