Depuy Ace Composite Locking Nut
FDA 510(k) K983265 · Depuy Ace Medical Co.
510(k) numberK983265
Submission
- Device name
- Depuy Ace Composite Locking Nut
- Applicant
- Depuy Ace Medical Co.
El Segundo, CA, US - Received
- September 17, 1998
- Decision date
- October 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K983853 | Depuy Ace Timax Meta PlateHRS · Traditional | 12/22/1998SE |
| K982347 | Depuy Ace Timax Pilon PlateHRS · Traditional | 08/31/1998SE |
| K981775 | Depuy Ace Timax Calcaneal Peri-Articular PlateHRS · Traditional | 07/29/1998SE |
| K974245 | Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…LXT · Traditional | 05/22/1998SE |
| K970503 | Depuy Ace Trochanteric Side PlateHRS · Traditional | 04/30/1997SE |
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Questions and answers
When was Depuy Ace Composite Locking Nut cleared by the FDA?
Depuy Ace Composite Locking Nut (K983265) received a 510(k) decision of Substantially Equivalent on October 26, 1998, 39 days after the submission was received.
What is the product code of K983265?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.