Spinal Specialties, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Spinal Specialties, Inc.” (first 1994, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 162 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 5 | 5 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| IZG | System, X-Ray, Photofluorographic | 1 | 1 |
Review panels
- Anesthesiology (7)
- Radiology (1)
Most recent Spinal Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960100 | SPINAL SPECIALTIES NERVE BLOCK TRAY | CAZ | 1996-04-24 | 104 |
| K960082 | DISCOGRAPHY KIT | IZG | 1996-03-21 | 70 |
| K942863 | EPIDURAL NEEDLE | BSP | 1995-08-11 | 420 |
| K950820 | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE | BSP | 1995-06-30 | 127 |
| K944029 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | CAZ | 1995-06-30 | 317 |
| K943319 | GERTIE MARX EPI-SPINAL TRAY | CAZ | 1995-06-30 | 354 |
| K941343 | SPINAL ANESTHESIA TRAY | CAZ | 1994-08-11 | 143 |
| K935245 | EPIDURAL ANESTHESIA TRAY | CAZ | 1994-05-02 | 182 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-04-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Spinal Elements, Inc. (50 510(k)s)
- Spinal Concepts, Inc. (33 510(k)s)
- Spinal USA (24 510(k)s)
- Spinal Simplicity, LLC (16 510(k)s)
- Spinal Innovations, LLC (5 510(k)s)
- Spinal Resources, Inc. (4 510(k)s)
- Spinal Edge, LLC (3 510(k)s)
- Spinal Analytics & Geometrical Implant Co, LLC (2 510(k)s)
- Spinal Balance, Inc. (2 510(k)s)
- Spinal Devices, LLC (2 510(k)s)
- Spinal Kinetics, LLC (1 510(k)s)
- Spinal Acoustics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spinal Specialties, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Spinal Specialties, Inc.” (first 1994, latest 1996), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spinal Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinal Specialties, Inc. is 162 days.
Which FDA product codes appear under Spinal Specialties, Inc.?
The most frequent FDA product codes under this applicant name are CAZ (Anesthesia Conduction Kit, 5); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 2); IZG (System, X-Ray, Photofluorographic, 1).
Next steps
- See all 8 Spinal Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Spinal Specialties, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.