Gladiator Bipolar System
FDA 510(k) K062693 · Wrightmedicaltechnologyinc
510(k) numberK062693
Submission
- Device name
- Gladiator Bipolar System
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- September 11, 2006
- Decision date
- September 29, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | Heraeus Medical GmbH | 11/01/2019SE |
| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
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Questions and answers
When was Gladiator Bipolar System cleared by the FDA?
Gladiator Bipolar System (K062693) received a 510(k) decision of Substantially Equivalent on September 29, 2006, 18 days after the submission was received.
What is the product code of K062693?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.