Spinal Concepts, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Spinal Concepts, Inc.” (first 1997, latest 2005), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | 5 | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| MQP | Spinal Vertebral Body Replacement Device | 5 | 5 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (32)
- Neurology (1)
Most recent Spinal Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | MQP | 2005-05-19 | 29 |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | GZT | 2005-04-15 | 28 |
| K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | KWP | 2004-07-01 | 163 |
| K033663 | SPINAL CONCEPTS INC. CODA | MQP | 2004-05-27 | 188 |
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS | MQP | 2004-02-18 | 103 |
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM | KWQ | 2003-09-17 | 93 |
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM | MNI | 2003-09-11 | 76 |
| K031318 | TRAXIS CEMENT RESTRICTOR | JDK | 2003-08-22 | 119 |
| K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM | MQP | 2003-08-07 | 69 |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | JDK | 2003-07-24 | 38 |
23 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2004-04-01.
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 USA (24 510(k)s)
- Spinal Simplicity, LLC (16 510(k)s)
- Spinal Specialties, Inc. (8 510(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 Concepts, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Spinal Concepts, Inc.” (first 1997, latest 2005), across 11 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 Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinal Concepts, Inc. is 72 days.
Which FDA product codes appear under Spinal Concepts, Inc.?
The most frequent FDA product codes under this applicant name are JDK (Prosthesis, Hip, Cement Restrictor, 5); KWP (Appliance, Fixation, Spinal Interlaminal, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5).
Next steps
- See all 33 Spinal Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDK, Spinal Concepts, 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.