Ace 100 Degrees Tubular Plate
FDA 510(k) K920738 · Ace Orthopedic Manufacturing Co.
510(k) numberK920738
Submission
- Device name
- Ace 100 Degrees Tubular Plate
- Applicant
- Ace Orthopedic Manufacturing Co.
Los Angeles, CA, US - Received
- February 19, 1992
- Decision date
- July 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
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| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
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| K934962 | Aim Supracondylar NailHSB · Traditional | 03/22/1994SE |
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| K936045 | Ace Unilateral Fixator IIJEC · Traditional | 02/22/1994SE |
| K926047 | Ace 8.0MM Cannulated Cancellous Bone ScrewHWC · Traditional | 03/31/1993SE |
| 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 100 Degrees Tubular Plate cleared by the FDA?
Ace 100 Degrees Tubular Plate (K920738) received a 510(k) decision of Substantially Equivalent on July 27, 1992, 159 days after the submission was received.
What is the product code of K920738?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.