Advanced Spine Fixation Systems, Inc.
Washington, D.C., DC, US
Advanced Spine Fixation Systems, Inc. appears in FDA device records in Washington, D.C., DC. 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 Advanced Spine Fixation Systems, Inc. between 1989 and 2000. The busiest year on record is 1995, with 8. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 8 |
| 1996 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992012 | WILTSE SYSTEM | KWQ | Substantially Equivalent | |
| K990845 | MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 | KWP | Substantially Equivalent | |
| K954770 | CENTRA-LINE GRAPPLE, VARIFIX SYSTEM | KWP | Substantially Equivalent | |
| K953779 | SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM | MNH | Substantially Equivalent for Some Indications | |
| K953778 | SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM | MNH | Substantially Equivalent for Some Indications | |
| K953369 | STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW | MNH | Substantially Equivalent for Some Indications | |
| K951308 | 5.8MM DIAMETER ANCHOR SCREW | MNH | Substantially Equivalent for Some Indications | |
| K951172 | TITANIUM LOW PROFILE CROSS BAR | MNH | Substantially Equivalent | |
| K945064 | SELBY INSTRUMENTATION | MNH | Substantially Equivalent | |
| K943775 | SELBY INSTRUMENTATION | MNH | Substantially Equivalent for Some Indications | |
| K942387 | SELBY INSTRUMENTATION | MNH | Substantially Equivalent for Some Indications | |
| K931225 | LOW PROFILE MID CROSS BRACING | KWP | Substantially Equivalent for Some Indications | |
| K931208 | LOW PROFILE SLEAVE NUT ASSEMBLY | KWP | Substantially Equivalent for Some Indications | |
| K924474 | SELBY INSTRUMENTATION | KWP | Substantially Equivalent | |
| K920102 | THE SELBY SYSTEM | KWP | Substantially Equivalent | |
| K884998 | SELBY INSTRUMENTATION | KWP | Substantially Equivalent for Some Indications |
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