Data / Medical devices / United States / Biomimetic Therapeutics,llc
Biomimetic Therapeutics,llc: FDA-registered device maker in Franklin, TN, United States, 1 PMA approval
Biomimetic Therapeutics,llc is registered with the FDA (registration 3003897776) in Franklin, TN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated September 1, 2015. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3003897776
- Address
- 389 Nichol Mill Ln, Franklin, TN, United States, 37067
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 28, 2021
- Registered through
- 2027
- Brand names listed
- Augment Bone Graft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Synthetic Peptide | NOX | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 1, 2015 | P100006 | AUGMENT BONE GRAFT | NOX | 12 | June 13, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 23, 2021 | 88395 | Class II | Terminated | AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 | The kit contains the wrong vial tray in the package. | accessdata.fda.gov |
Compare with other makers
Updated June 13, 2022. 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.