Neoortho Produtos Ortopedicos S/a
Curitiba Parana, BR
NEOORTHO PRODUTOS ORTOPEDICOS S/A appears in FDA device records in Curitiba Parana, BR. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Neoortho Produtos Ortopedicos S/a between 2010 and 2022. The busiest year on record is 2014, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221021 | Femoral Trochanteric Nail System – Neonail | HSB | Substantially Equivalent | |
| K162874 | Cannulated Screws Neoortho | HWC | Substantially Equivalent | |
| K141103 | INTRAMEDULLARY NAIL AND SCREWS-NEONAIL | HSB | Substantially Equivalent | |
| K132852 | PEEK CAGE FOR THE VERTEBRAL SPINE | MAX | Substantially Equivalent | |
| K113733 | SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX | HRS | Substantially Equivalent | |
| K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | JEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009158523 | 3009158523 | NEOORTHO PRODUTOS ORTOPEDICOS S/A | Rua Angelo Domingos Durigan, 607, Curitiba Parana 82025-100 BR | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- GFFBur, Surgical, General & Plastic Surgery
- HXDClamp
- GENForceps, General & Plastic Surgery
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- MDMInstrument, Manual, Surgical, General Use
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- FTNPlastic Surgery And Accessories Kit
- JEYPlate, Bone
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- HWTTemplate
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- KTETrocar, Ent
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Neoortho Produtos Ortopedicos S/a edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain