Neer-Iii Solid Keel Glenoid Resurfacing Prosthesis
FDA 510(k) K873621 · Kirschner Medical Corp.
510(k) numberK873621
Submission
- Device name
- Neer-Iii Solid Keel Glenoid Resurfacing Prosthesis
- Applicant
- Kirschner Medical Corp.
Timonium, MD, US - Received
- September 8, 1987
- Decision date
- October 15, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
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More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | 08/29/1995SE |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional | 01/18/1995SE |
| K942891 | Summit Total Hip SystemMEH · Traditional | 11/02/1994SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935951 | Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional | 07/18/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K920188 | Threaded PinsMBJ · Traditional | 05/12/1993SE |
Questions and answers
When was Neer-Iii Solid Keel Glenoid Resurfacing Prosthesis cleared by the FDA?
Neer-Iii Solid Keel Glenoid Resurfacing Prosthesis (K873621) received a 510(k) decision of Substantially Equivalent for Some Indications on October 15, 1987, 37 days after the submission was received.
What is the product code of K873621?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.