Scient'X
Round Rock, TX, US
Scient'X appears in FDA device records in Round Rock, TX. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Scient'X between 2004 and 2008. The busiest year on record is 2004, with 6. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 6 |
| 2005 | 4 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | NQP | Substantially Equivalent | |
| K062912 | SCIENT'X SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K052763 | STELLA CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K052367 | SCIENT'X CEMENT RESTRICTOR | JDK | Unknown | |
| K050348 | CO VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K051063 | POLYAXIAL HEMISPHERICAL SPINAL SCREWS | MNI | Substantially Equivalent | |
| K043001 | MX POLYAXIAL PEDICLE SCREW | MNH | Substantially Equivalent | |
| K042964 | MX MONOAXIAL PEDICLE SCREW | MNH | Substantially Equivalent | |
| K042317 | CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K040747 | ALADYN RIGID SPINE PLATE | MNH | Substantially Equivalent | |
| K040454 | BIOFILL BONE VOID FILLER | MQV | Substantially Equivalent | |
| K033109 | ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS | MQP | 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