Orthomedics
Mchenry, IL, US
Orthomedics appears in FDA device records in Mchenry, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Orthomedics between 1980 and 1983. The busiest year on record is 1981, with 7. The most recent is 1983, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 6 |
| 1981 | 7 |
| 1983 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | ITM | Substantially Equivalent | |
| K832741 | JASON CERVICAL ORTHOSIS | IQF | Substantially Equivalent | |
| K832740 | FEMORAL FRACTURE ORTHOSIS | Substantially Equivalent | ||
| K811456 | ORTHO-FRAC KIT | IQI | Substantially Equivalent | |
| K811298 | EXECUTIVE COLLAR | IQK | Substantially Equivalent | |
| K811297 | CERVICAL SUPPORT | IQF | Substantially Equivalent | |
| K810557 | HIP ABDUCTION SPLINT | IOZ | Substantially Equivalent | |
| K810556 | SPINAL EXTENSION BRACE | IPY | Substantially Equivalent | |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | IQF | Substantially Equivalent | |
| K810554 | LUMBAR FLEXION BRACE | IPY | Substantially Equivalent | |
| K803033 | CRUSADER HYPEREXTENSION BRACE | IPY | Substantially Equivalent | |
| K802910 | PLASTIC FRACTURE CAST BRACE KNEE JOINT | IQI | Substantially Equivalent | |
| K802911 | A/K SOCKET | ISS | Substantially Equivalent | |
| K802909 | HUMERAL FRACTURE BRACE | IQI | Substantially Equivalent | |
| K802908 | ULNAR FRACTURE BRACE | IQI | Substantially Equivalent | |
| K802871 | TIBIAL FRACTURE BRACE | IQI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain
