Surgical Simplex P with Tobramycin
FDA 510(k) K014199 · Howmedica Osteonics Corp.
510(k) numberK014199
Submission
- Device name
- Surgical Simplex P with Tobramycin
- Applicant
- Howmedica Osteonics Corp.
Allendale, NJ, US - Received
- December 21, 2001
- Decision date
- May 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOD – Bone Cement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| K212729 | Bone Cement-Normal ViscosityLOD · Traditional | Biomecanica Industria E Comerciode Produtos… | 05/31/2022SE |
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Questions and answers
When was Surgical Simplex P with Tobramycin cleared by the FDA?
Surgical Simplex P with Tobramycin (K014199) received a 510(k) decision of Substantially Equivalent on May 6, 2003, 501 days after the submission was received.
What is the product code of K014199?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.