Lag Screw
FDA 510(k) K905342 · O'Tec Corp.
510(k) numberK905342
Submission
- Device name
- Lag Screw
- Applicant
- O'Tec Corp.
Memphis, TN, US - Received
- November 28, 1990
- Decision date
- December 11, 1990
- 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
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| 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 |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943293 | SCC22/ SCC26 Shower Commode ChairIOR · Traditional | 08/19/1994SE |
| K910093 | Futura Femoral Hip StemJDI · Traditional | 07/01/1991SE |
| K905358 | Cancellous ScrewHWC · Traditional | 01/04/1991SN |
| K905357 | Cortical Bone Screw (European Style)HWC · Traditional | 01/04/1991SN |
| K905355 | Broad Self-Compressing PlateHRS · Traditional | 01/04/1991SN |
| K905347 | Hagie PinJDW · Traditional | 01/04/1991SN |
| K905333 | U.S. Type Cruciate Slot Bone ScrewHWC · Traditional | 01/04/1991SN |
| K905364 | Round StapleJDR · Traditional | 12/11/1990SE |
| K905363 | Fixation StapleJDR · Traditional | 12/11/1990SE |
| K905362 | Barbed Square StapleJDR · Traditional | 12/11/1990SE |
Questions and answers
When was Lag Screw cleared by the FDA?
Lag Screw (K905342) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 13 days after the submission was received.
What is the product code of K905342?
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.