Company ยท US
Core Essence Orthopaedics, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2011. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 2011 | K111716 | KNOTLESS SUTURE FIXATION SYSTEM Core Essence Orthopaedics | MBI |
| Dec 2, 2010 | K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS Core Essence Orthopaedics, Inc. | MBI |
| Mar 19, 2009 | K090128 | TAC-TITE (TM) Core Essence Orthopaedics, Inc. | GAT |
| Dec 24, 2008 | K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 Core Essence Orthopaedics, LLC | GAQ |
| Aug 15, 2007 | K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES Core Essence Orthopaedics, LLC | JDR |
| Aug 10, 2007 | K071520 | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X Core Essence Orthopaedics, LLC | MBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||