Core Essence Orthopaedics, LLC
United StatesFDA applicant, unverified
- Devices
- 6
What Core Essence Orthopaedics, LLC makes
Core Essence Orthopaedics, LLC manufactures orthopaedic fixation devices, including shape memory staples (REVERTO 55 and 37), suture anchors (RENOVO, models 100-2001 through 100-5502X), and stainless steel sutures (FERROFIBRE, Model 610 series, USP sizes 5-0 to #5). These products are designed for soft tissue and bone repair in surgical procedures.
The company’s devices fall under FDA Class II regulation and are listed via 510(k) clearance. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
Knotless Suture Fixation System Ref K111716
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Reverto 55 And 37 Shape Memory Staples Ref K071477
Regimes: 510(k) Registry: 510(k)Tac-Tite (Tm) Ref K090128
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Core Essence Orthopaedics, LLC have in the registry?
The registry currently lists 6 devices for Core Essence Orthopaedics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Core Essence Orthopaedics, LLC's devices?
Among its 6 most recently registered devices, Core Essence Orthopaedics, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Core Essence Orthopaedics, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Core Essence Orthopaedics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Core Essence Orthopaedics, LLC in the registry?
The most recently registered devices listed for Core Essence Orthopaedics, LLC include KNOTLESS SUTURE FIXATION SYSTEM, PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS, REVERTO 55 AND 37 SHAPE MEMORY STAPLES and TAC-TITE (TM).