FLOWER SMALL AND MEDIUM BONE IMPLANTS— 510(k) K123562
Substantially EquivalentFlower Orthopedics Corporation
FDA 510(k) clearance K123562 for FLOWER SMALL AND MEDIUM BONE IMPLANTS, Substantially Equivalent on 2013-03-29. Applicant: Flower Orthopedics Corporation. Device class: 2.
Clearance details
- Applicant
- Flower Orthopedics Corporation
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philedelphia, PA, US
Recent devices under product code HRS
view allMore clearances from Flower Orthopedics Corporation
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K123562
K-number listed on FDA's recall record- Z-0034-2022 — Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- Z-1314-2015 — Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123562.
Data sourced from openFDA. This site is unofficial and independent of the FDA.