Spinal Specialties, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Spinal Specialties, Inc. makes
Spinal Specialties, Inc. manufactures spinal anesthesia and nerve block trays, epidural anesthesia trays, discography kits, spinal needles including pencil-point spinal needles, and epidural needles.
The company's devices are classified as Class II and are listed in the FDA 510(k) registry; the manufacturer is based in the United States.
Catalogue
Spinal Specialties Nerve Block Tray Ref K960100
Regimes: 510(k) Registry: 510(k)Epidural Anesthesia Tray Ref K935245
Regimes: 510(k) Registry: 510(k)Discography Kit Ref K960082
Regimes: 510(k) Registry: 510(k)Spinal Specialties Pencil-Point Spinal Needle Ref K950820
Regimes: 510(k) Registry: 510(k)Continuous Epidural Anesthesia Tray Ref K944029
Regimes: 510(k) Registry: 510(k)Spinal Anesthesia Tray Ref K941343
Regimes: 510(k) Registry: 510(k)Gertie Marx Epi-Spinal Tray Ref K943319
Regimes: 510(k) Registry: 510(k)Epidural Needle Ref K942863
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Spinal Specialties, Inc., the earliest on 2004-06-18 and the most recent on 2005-04-15. By recorded status: 4 terminated. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 15 Apr 2005 Z-0885-05 Unclassified (pre-2012) Terminated Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
- 15 Apr 2005 Z-0886-05 Unclassified (pre-2012) Terminated Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
2004
- 18 Jun 2004 Z-1113-04 Unclassified (pre-2012) Terminated Kit contains lidocaine, which has particulate matter in its ampule.
- 18 Jun 2004 Z-1114-04 Unclassified (pre-2012) Terminated Kit contains lidocaine, which has particulate matter in its ampule.
Frequently asked questions
How many devices does Spinal Specialties, Inc. have in the registry?
The registry currently lists 8 devices for Spinal Specialties, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spinal Specialties, Inc.'s devices?
Among its 8 most recently registered devices, Spinal Specialties, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Spinal Specialties, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Spinal Specialties, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spinal Specialties, Inc.?
FDA recall records list 4 recalls initiated by Spinal Specialties, Inc., the most recent initiated on 15 Apr 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Spinal Specialties, Inc. in the registry?
The most recently registered devices listed for Spinal Specialties, Inc. include SPINAL SPECIALTIES NERVE BLOCK TRAY, EPIDURAL ANESTHESIA TRAY, DISCOGRAPHY KIT and SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE.