Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
- 510(k)K152047Substantially equivalent (SESE) · 2015-12-23clearance family
Predicate lineage
Cited as predicate by: K193560, K212569, K213827, K220452, K220847, K230315, K230572, K231112, K233408, K241143, K242813, K260802
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-03-30 | NAI | No action indicated | Ascension Orthopedics, Inc | 0 |
| 2015-10-22 | NAI | No action indicated | Ascension Orthopedics, Inc | 0 |
| 2011-04-07 | VAI | Voluntary action indicated | Ascension Orthopedics, Inc | 1 |
| 2010-09-16 | WL | Warning Letter | Ascension Orthopedics, Inc | — |
| 2010-03-08 | OAI | Official action indicated | Ascension Orthopedics, Inc | 1 |
- TT MB Peg LIMACORPORATE SPA
- TT MB Peg LIMACORPORATE SPA
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