Arthroscopic Meniscal Suture System
FDA 510(k) K871323 · Orthopedic Systems, Inc.
510(k) numberK871323
Submission
- Device name
- Arthroscopic Meniscal Suture System
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- April 3, 1987
- Decision date
- May 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWT – Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Specialty
- Orthopedic
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| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
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| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
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Questions and answers
When was Arthroscopic Meniscal Suture System cleared by the FDA?
Arthroscopic Meniscal Suture System (K871323) received a 510(k) decision of Substantially Equivalent on May 1, 1987, 28 days after the submission was received.
What is the product code of K871323?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.