Spinal Specialties, Inc.
San Antonio, TX, US
Spinal Specialties, Inc. appears in FDA device records in San Antonio, TX. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Spinal Specialties, Inc. between 1994 and 1996. The busiest year on record is 1995, with 4. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960100 | SPINAL SPECIALTIES NERVE BLOCK TRAY | CAZ | Substantially Equivalent | |
| K960082 | DISCOGRAPHY KIT | IZG | Substantially Equivalent | |
| K942863 | EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K950820 | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K944029 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | CAZ | Unknown | |
| K943319 | GERTIE MARX EPI-SPINAL TRAY | CAZ | Unknown | |
| K941343 | SPINAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | |
| K935245 | EPIDURAL ANESTHESIA TRAY | CAZ | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0886-05 | 22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas. | Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub. | Terminated | ||
| Z-0885-05 | Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas. | Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub. | Terminated | ||
| Z-1114-04 | Pencil Point Spinal Tray, Lot number 0504243 | Kit contains lidocaine, which has particulate matter in its ampule. | Terminated | ||
| Z-1113-04 | Gertie Marx PainPak, Lot number 0504305, Reorder number 4060 | Kit contains lidocaine, which has particulate matter in its ampule. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain