Ace Humeral Nail
FDA 510(k) K934643 · Ace Orthopedic Manufacturing Co.
510(k) numberK934643
Submission
- Device name
- Ace Humeral Nail
- Applicant
- Ace Orthopedic Manufacturing Co.
Los Angeles, CA, US - Received
- September 29, 1993
- Decision date
- March 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K934962 | Aim Supracondylar NailHSB · Traditional | 03/22/1994SE |
| K936045 | Ace Unilateral Fixator IIJEC · Traditional | 02/22/1994SE |
| K926047 | Ace 8.0MM Cannulated Cancellous Bone ScrewHWC · Traditional | 03/31/1993SE |
| K920738 | Ace 100 Degrees Tubular PlateHRS · Traditional | 07/27/1992SE |
| K813554 | Ace/Kyle Captured Hip ScrewKTT · Traditional | 01/12/1982SE |
| K810193 | Trippi-Wells Dual Purpose Universal TongHAX · Traditional | 03/20/1981SE |
| K801594 | Ace Fischer External Fixation DeviceHXK · Traditional | 09/09/1980SE |
| K791466 | Ace External Bone Clamp Part #S11JEC · Traditional | 08/16/1979SE |
| K781841 | Bar, DistractionJEC · Traditional | 11/08/1978SE |
| K781840 | External ArticulationJEC · Traditional | 11/08/1978SE |
Questions and answers
When was Ace Humeral Nail cleared by the FDA?
Ace Humeral Nail (K934643) received a 510(k) decision of Substantially Equivalent on March 22, 1994, 174 days after the submission was received.
What is the product code of K934643?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.