Radiographic Markers
FDA 510(k) K011856 · Encore Orthopedics, Inc.
510(k) numberK011856
Submission
- Device name
- Radiographic Markers
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- June 13, 2001
- Decision date
- August 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
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| K020741 | Unicondylar KneeHRY · Traditional | 06/04/2002SE |
| K020236 | Modification to Pass Spinal SystemKWP · Special | 02/14/2002SE |
| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | 12/06/2001SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
Questions and answers
When was Radiographic Markers cleared by the FDA?
Radiographic Markers (K011856) received a 510(k) decision of Substantially Equivalent on August 22, 2001, 70 days after the submission was received.
What is the product code of K011856?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.