FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
FDA 510(k) K241219 · ZuriMED Technologies AG
510(k) numberK241219
Submission
- Device name
- FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
- Applicant
- ZuriMED Technologies AG
Zurich, CH - Received
- May 1, 2024
- Decision date
- December 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWX – Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in tendon repair.
Other 510(k)s with product code OWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitOWX · Special | ZuriMED Technologies AG | 01/02/2026SE |
| K250997 | Integrity ImplantOWX · Traditional | Anika Therapeutics, Inc. | 06/17/2025SE |
| K243480 | SuturePatch Tissue ReinforcementOWX · Traditional | Arthrex, Inc. | 05/29/2025SE |
| K223538 | Integrity ImplantOWX · Traditional | Anika Therapeutics, Inc. | 08/17/2023SE |
More from Anika Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitOWX · Special | 01/02/2026SE |
Questions and answers
When was FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) cleared by the FDA?
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) received a 510(k) decision of Substantially Equivalent on December 11, 2024, 224 days after the submission was received.
What is the product code of K241219?
The FDA product code is OWX – Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.