Intra-Arc Disposable Arthroplasty Burrs
FDA 510(k) K850645 · Concept, Inc.
510(k) numberK850645
Submission
- Device name
- Intra-Arc Disposable Arthroplasty Burrs
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- February 19, 1985
- Decision date
- March 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
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| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Intra-Arc Disposable Arthroplasty Burrs cleared by the FDA?
Intra-Arc Disposable Arthroplasty Burrs (K850645) received a 510(k) decision of Substantially Equivalent on March 6, 1985, 15 days after the submission was received.