Ortho Tec, LLC
Pleasant Hill, CA, US
Ortho Tec, LLC appears in FDA device records in Pleasant Hill, CA. FDA records list 22 510(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
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Ortho Tec, LLC between 1999 and 2004. The busiest year on record is 2003, with 10. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 10 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040514 | EOVIA CALCIUM PHOSPHATE CERAMIC | MQV | Substantially Equivalent | |
| K040346 | MODIFICATION TO ORIA TOP CLIP SYSTEM | MNI | Substantially Equivalent | |
| K030958 | ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS | MNI | Substantially Equivalent | |
| K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | KWP | Substantially Equivalent | |
| K023884 | MODIFICATION ORIA SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K023378 | ORIA CLARIS | MNH | Substantially Equivalent | |
| K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | KWP | Substantially Equivalent | |
| K030500 | ORIA ZENITH | KWQ | Substantially Equivalent | |
| K023377 | ORIA CERVICAL PLATES | KWQ | Substantially Equivalent | |
| K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | KWP | Substantially Equivalent | |
| K030252 | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) | KWP | Substantially Equivalent | |
| K023994 | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ | MNH | Substantially Equivalent | |
| K021679 | ORIA SPINAL CLIP SYSTEM | KWP | Substantially Equivalent | |
| K021919 | SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO | KWP | Substantially Equivalent | |
| K021379 | SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | MNI | Substantially Equivalent | |
| K011807 | SCS CLARIS SPINAL SCREWS, TYPES V,G,E | MNI | Substantially Equivalent | |
| K003823 | SCS DT-02 TRANSVERSE CONNECTOR | KWP | Substantially Equivalent | |
| K003733 | SCS CLOSED SCREW | MNH | Substantially Equivalent | |
| K010369 | CLARIS PLATE SYSTEM | MNH | Substantially Equivalent | |
| K001535 | ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION | KWP | Substantially Equivalent | |
| K994288 | 5.0MM SPINAL SCREWS | MNH | Substantially Equivalent | |
| K993926 | OMNIAXIAL CONNECTOR | MNH | 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