FDA Inspection
K2M, Inc.K2M, Inc. – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns K2M, Inc., with an inspection on October 12, 2017, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- K2M, Inc.
- Inspection Date
- October 12, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 33219586-6ec2-4d00-90ff-26bf4d5ac100
Inspection Facts
- Inspection number
- 1078529
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of K2M, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 27, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 16, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for K2M, Inc.
- FDA Inspection 1236122 - 2024-03-21
- FDA Inspection 1168720 - 2022-04-21
- FDA Inspection 1148726 - 2021-07-27
- FDA Inspection 1076835 - 2018-12-07
- FDA Inspection 992904 - 2016-11-16
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