Arthrex BioSync® Bone Wedge— 510(k) K151256
Substantially EquivalentArthex, Inc.
FDA 510(k) clearance K151256 for Arthrex BioSync® Bone Wedge, Substantially Equivalent on 2015-08-12. Applicant: Arthex, Inc.. Device class: 2.
Clearance details
- Applicant
- Arthex, Inc.
- Product code
- Code PLF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, US
Recent devices under product code PLF
view allMore clearances from Arthex, Inc.
view allRecalls naming K151256
K-number listed on FDA's recall record- Z-1958-2016 — BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1959-2016 — BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1960-2016 — BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1961-2016 — BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1962-2016 — BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1963-2016 — BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151256.
Data sourced from openFDA. This site is unofficial and independent of the FDA.