Mec Distal Femoral Bolt
FDA 510(k) K850403 · Pfizer, Inc.
510(k) numberK850403
Submission
- Device name
- Mec Distal Femoral Bolt
- Applicant
- Pfizer, Inc.
Ny, NY, US - Received
- February 1, 1985
- Decision date
- July 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
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| 510(k) | Device | Decision |
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| K181102 | ThermaCare Quick Therapy TENSNUH · Traditional | 09/15/2018SE |
| K991620 | Visine for ContactsLPN · Traditional | 09/24/1999SE |
| K892264 | Oralchek Super-Soft BrushEFW · Traditional | 06/14/1989SE |
| K892360 | Water Jel Sterile Gel-Soaked Burn DressingFRO · Traditional | 06/05/1989SE |
| K881378 | Pfizer Hospital Products Group Acl Drill GuideLXI · Traditional | 06/17/1988SE |
| K854726 | Medi-Wipes United Antiseptic Skin PrepEXB · Traditional | 02/24/1986SE |
| K850840 | Howmedica Threaded Acetabular ComponentKWA · Traditional | 07/15/1985SE |
| K850443 | Mec Rod ConnectorKTT · Traditional | 07/15/1985SE |
| K850413 | Mec Hip BoltKTT · Traditional | 07/15/1985SE |
| K851971 | Series 7000/HOLTER RecorderDSH · Traditional | 06/20/1985SE |
Questions and answers
When was Mec Distal Femoral Bolt cleared by the FDA?
Mec Distal Femoral Bolt (K850403) received a 510(k) decision of Substantially Equivalent on July 15, 1985, 164 days after the submission was received.
What is the product code of K850403?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.