Kyphon, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kyphon, Inc.” (first 1998, latest 2008), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 |
|---|---|---|---|
| HRX | Arthroscope | 4 | 4 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 3 | 3 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
Review panels
- Orthopedic (6)
- Anesthesiology (3)
Most recent Kyphon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073516 | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR | BSP | 2008-02-21 | 69 |
| K063071 | DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B | BSP | 2007-04-13 | 189 |
| K061210 | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B | BSP | 2006-06-27 | 57 |
| K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A | HRX | 2004-07-09 | 38 |
| K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A | NDN | 2004-07-07 | 23 |
| K033801 | KYPHX HV-R, MODEL C01A | NDN | 2004-04-01 | 115 |
| K032212 | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A | HRX | 2003-09-15 | 56 |
| K010246 | KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A | HRX | 2001-02-14 | 19 |
| K981251 | KYPHON INFLATABLE BONE TAMP | HRX | 1998-07-02 | 87 |
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2008-06-23.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kyphon, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Kyphon, Inc.” (first 1998, latest 2008), 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 Kyphon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kyphon, Inc. is 57 days.
Which FDA product codes appear under Kyphon, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 4); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 3); NDN (Cement, Bone, Vertebroplasty, 2).
Next steps
- See all 9 Kyphon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Kyphon, 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.