RECON system-V-TEK-IVP Plates and Screws
FDA 510(k) clearance K152312 · decided 2015-10-30
Clearance details
- K-number
- K152312
- Device name
- RECON system-V-TEK-IVP Plates and Screws
- Applicant
- Normed Medizin-Technik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-08-17
- Decision date
- 2015-10-30
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.