Sofamor Danek Mfg., Inc.
Memphis, TN, US
Sofamor Danek Mfg., Inc. appears in FDA device records in Memphis, TN. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Sofamor Danek Mfg., Inc. between 1992 and 1995. The busiest year on record is 1993, with 12. The most recent is 1995, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 8 |
| 1993 | 12 |
| 1995 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS | KWP | Substantially Equivalent for Some Indications | |
| K930191 | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY | HRX | Substantially Equivalent | |
| K932029 | TSRH SPINAL SCREWS | MNH | Substantially Equivalent | |
| K922486 | DANEK TISSUE CUTTING AND REMOVAL SYSTEM | HRX | Substantially Equivalent for Some Indications | |
| K930807 | SENTRY ANTERIOR SPINAL SYSTEM | KWQ | Substantially Equivalent | |
| K930710 | SENTRY POSTERIOR SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K923242 | CROSSLINK AXIAL AND OFFSET PLATES | KWQ | Substantially Equivalent for Some Indications | |
| K922543 | Z-PLATE ANTERIOR FIXATION SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K925811 | TSRH CENTRAL POST HOOKS | KWP | Substantially Equivalent for Some Indications | |
| K922672 | AUGMENT POSTERIOR SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent for Some Indications | |
| K921256 | LUQUE V SPINAL SYSTEM | KWP | Substantially Equivalent for Some Indications | |
| K925577 | DANEK TISSUE RESECTING SYSTEM | HRX | Substantially Equivalent | |
| K925812 | TITANIUM SONGER CABLE SYSTEM | JDQ | Substantially Equivalent | |
| K920118 | RESORABPLUG | LZN | Substantially Equivalent | |
| K920546 | PARAGON POSTERIOR SPINAL SYSTEM | KWP | Substantially Equivalent for Some Indications | |
| K924085 | RECONSTRUCTION PLATE SYSTEM | HRS | Substantially Equivalent for Some Indications | |
| K923446 | STERILE DYNA LOK ANTERIOR PLATING SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K922520 | MODIFIED TSRH CENTRAL POST HOOKS | KWP | Substantially Equivalent | |
| K922087 | ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K923339 | TSRH L CONNECTOR -- MODIFICATION | KWP | Substantially Equivalent | |
| K914306 | TSRH(TM) LATERAL OFFSET PLATE | KWP | Substantially Equivalent | |
| K914966 | TSRH CENTRAL POST HOOKS | KWP | Substantially Equivalent | |
| K920201 | TITANIUM ALLOY SONGER CABLE SYSTEM | JDQ | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain