Ace Beaded K-Wires Ace Olive Wires
FDA 510(k) K895079 · Buckman Co., Inc.
510(k) numberK895079
Submission
- Device name
- Ace Beaded K-Wires Ace Olive Wires
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- August 14, 1989
- Decision date
- September 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
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| K950099 | Synergy(Tm) Ti Posterior Spinal SystemMNH · Traditional | 01/16/1997SN |
| K960451 | Webb-Morley Spine SystemMNH · Traditional | 04/18/1996SN |
| K950999 | KSF Posterior Spingal Fixator for Severe SpondylolisthesisMNH · Traditional | 01/25/1996SE |
| K945756 | Imagn(Tm) 2000 SystemGKZ · Traditional | 12/19/1995SE |
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| K951117 | Lihtan 532 LaserGEX · Traditional | 10/18/1995SE |
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Questions and answers
When was Ace Beaded K-Wires Ace Olive Wires cleared by the FDA?
Ace Beaded K-Wires Ace Olive Wires (K895079) received a 510(k) decision of Substantially Equivalent on September 13, 1989, 30 days after the submission was received.
What is the product code of K895079?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.