Data / Medical devices / Finland / Bioretec Ltd.
Bioretec Ltd.: FDA-registered device maker in Tampere Pirkanmaa, Finland, 5 510(k) clearances
Bioretec Ltd. is registered with the FDA (registration 3005536892) in Tampere Pirkanmaa, Finland. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005536892
- Address
- Yrittajankulma 5, Tampere Pirkanmaa, Finland, FI-33710
- Owner or operator
- Bioretec Ltd. (9093133)
- Roles
- Manufacturer
- First device listed
- January 2, 2008
- Registered through
- 2026
- Brand names listed
- Activa, Activa Instrument, Activa Instruments, ActivaNailTM Conical, ActivaPinTM, ActivaScrew, ActivaScrew Cannulated, ActivaScrew Cannulated COM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Metallic Bone Fixation Fastener | QJD | 2 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2026 | K261057 | ActivaScrew Cannulated COM | HWC | Substantially Equivalent | Bioretec, Ltd. | accessdata.fda.gov |
| March 29, 2023 | DEN220030 | RemeOs Screw LAG Solid | QJD | Unknown | Bioretec, Ltd. | accessdata.fda.gov |
| August 28, 2013 | K130716 | BIORETEC ACTIVASCREW INTERFERENCE | MAI | Substantially Equivalent | Bioretec, Ltd. | accessdata.fda.gov |
| June 24, 2008 | K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | HTY | Substantially Equivalent | Bioretec, Ltd. | accessdata.fda.gov |
| June 18, 2008 | K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN | HWC | Substantially Equivalent | Bioretec, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Screw, Fixation, Bone
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.