Sulzer Spine-Tech: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sulzer Spine-Tech” (first 1999, latest 2002), plus 1 PMA decision, across 6 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 0 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Sulzer Spine-Tech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022374 | CADENCE SPINAL FIXATION SYSTEM | KWP | 2002-09-24 | 64 |
| K020344 | RPX TITANIUM CEMNT RESTRICTOR | JDK | 2002-05-02 | 90 |
| K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | MNH | 2002-02-15 | 24 |
| K012173 | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | KWP | 2001-09-28 | 78 |
| K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2001-08-22 | 30 |
| K993067 | SILHOUETTE SPINAL FIXATION SYSTEM | KWP | 1999-11-16 | 64 |
| K992276 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | MNI | 1999-10-01 | 86 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980048 | PMA | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | 2001-04-20 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-17.
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.
- Sulzer Orthopedics, Inc. (45 510(k)s)
- Sulzer Calcitek, Inc. (9 510(k)s)
- Sulzer Dental, Inc. (9 510(k)s)
- Sulzer Carbomedics, Inc. (8 510(k)s)
- Sulzer Intratherapeutics, Inc. (8 510(k)s)
- Sulzer Oscor, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sulzer Spine-Tech?
FDA lists 7 510(k) clearances under the applicant name “Sulzer Spine-Tech” (first 1999, latest 2002), plus 1 PMA decision, across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sulzer Spine-Tech?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sulzer Spine-Tech is 64 days.
Which FDA product codes appear under Sulzer Spine-Tech?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 3); JDK (Prosthesis, Hip, Cement Restrictor, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 7 Sulzer Spine-Tech clearances with predicates and recalls
- Run predicate analysis for product code KWP, Sulzer Spine-Tech'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.