K140414 is an FDA 510(k) clearance for the IMBIBE NEEDLE. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Orthovita, Inc. (Malvern, US). The FDA issued a Cleared decision on April 1, 2014, 42 days after receiving the submission on February 18, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K140414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | April 01, 2014 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |