Osteomed Corp.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under 2 spellings of the applicant name “Osteomed Corp.” (first 1991, latest 2021), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 113 days. Since 2017 the median was 204 days, against 108 days for all cleared 510(k)s in the same product codes. 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 | 1 | 113 |
| 2013 | 3 | 101 |
| 2014 | 2 | 135 |
| 2015 | 3 | 140 |
| 2016 | 1 | 36 |
| 2017 | 2 | 226 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 89 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osteomed Corp. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 10 | 10 |
| DZL | Screw, Fixation, Intraosseous | 5 | 5 |
| HRS | Plate, Fixation, Bone | 5 | 5 |
| JEY | Plate, Bone | 4 | 4 |
| KMW | Handpiece, Rotary Bone Cutting | 2 | 2 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 | 2 |
| MQN | External Mandibular Fixator And/Or Distractor | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| HAE | Rongeur, Manual | 1 | 1 |
Plus 6 more product codes.
Review panels
- Orthopedic (21)
- Dental (14)
- Neurology (4)
Most recent Osteomed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | HRS | 2021-02-24 | 89 |
| K162542 | OsteoMed PINNACLE Driver | HBE | 2017-05-19 | 249 |
| K162544 | OsteoMed PINNACLE Driver | KMW | 2017-04-04 | 204 |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | HRS | 2016-05-19 | 36 |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | HRS | 2015-12-21 | 140 |
| K151195 | OsteoMed IMF Screw | DZL | 2015-09-21 | 140 |
| K151021 | OsteoMed Cannulated Screw System | HWC | 2015-07-15 | 90 |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | JEY | 2014-12-18 | 246 |
| K140283 | OSTEOMED EXTREMIFUSE SYSTEM | HWC | 2014-02-28 | 24 |
| K131851 | OSTEOMED NEURO RONGEUR | HAE | 2013-12-06 | 168 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteomed Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Osteomed Corp. (27)
- Osteomed (12)
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.
- Osteomed LP (29 510(k)s)
- Osteomed, LLC (5 510(k)s)
- Osteomed Implantes, Ltda (3 510(k)s)
- Osteomed Indústria E Comércio DE Implantes Ltda (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osteomed Corp.?
FDA lists 39 510(k) clearances under 2 spellings of the applicant name “Osteomed Corp.” (first 1991, latest 2021), across 16 product codes in 3 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 Osteomed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteomed Corp. is 113 days. Since 2017: 204 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osteomed Corp.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 10); DZL (Screw, Fixation, Intraosseous, 5); HRS (Plate, Fixation, Bone, 5).
Next steps
- See all 39 Osteomed Corp. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Osteomed Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.