Osteotech, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Osteotech, Inc.” (first 1985, latest 2008), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 4 | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 4 | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| NUN | Bone Grafting Material, Human Source | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (19)
- Dental (3)
- Pathology (1)
- General and Plastic Surgery (1)
Most recent Osteotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | MQV | 2008-10-16 | 37 |
| K081227 | PLEXUR M | MQV | 2008-07-22 | 83 |
| K080511 | PLEXUR-P | MQV | 2008-04-21 | 56 |
| K073405 | PLEXUR M | MQV | 2008-03-03 | 90 |
| K061982 | PLEXUR P | MBP | 2007-02-07 | 209 |
| K051188 | GRAFTON DBM | NUN | 2006-01-03 | 238 |
| K051781 | GRAFTCAGE TLX | MQP | 2005-12-16 | 168 |
| K051195 | GRAFTON DBM | MBP | 2005-12-16 | 220 |
| K043209 | VIAGRAF DBM PASTE | MBP | 2005-12-05 | 381 |
| K053080 | GRAFTCAGE ACX | MQP | 2005-12-01 | 29 |
14 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-04-20.
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.
Device clinical trials
An industry sponsor named Osteotech, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00837473: Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures (Completed, started 2009-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Osteotech, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Osteotech, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Osteotech, Inc.” (first 1985, latest 2008), across 10 product codes in 4 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 Osteotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteotech, Inc. is 89 days.
Which FDA product codes appear under Osteotech, Inc.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 5); MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), 4); MQP (Spinal Vertebral Body Replacement Device, 4).
Next steps
- See all 24 Osteotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Osteotech, 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.