Greeley
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
26- Orthopaedic Surgery
- 26
How orthopedic groups in this region vet a new vendor
Surgery centers and orthopedic group practices typically assign vendor review to a compliance officer or physician committee before a new tissue product line is approved. That review generally starts with the supplier's processing description and moves to lot-specific paperwork.
For Wharton's jelly allografts, many committees also want to see how the supplier frames its HCT/P regulatory posture, and will independently confirm with their own counsel whether a given use is expected to meet the minimal manipulation and homologous use standard in 21 CFR 1271.10.
- Certificate of analysis for the specific lot
- Donor eligibility and screening summary
- Lot release and sterility testing record
NPI-verified accounts
An account requires a valid NPI number for the responsible physician, checked against the public registry before pricing is shared. Multi-site surgery center groups typically centralize ordering under one or more supervising physicians.
Shipping biologics to the Mountain West
Cryopreserved Wharton's jelly and exosome formats are frozen at -80 degrees Celsius and ship overnight on dry ice in validated containers regardless of destination. Receiving staff should confirm the shipment held temperature and record the lot number before the product enters storage.
Lyophilized formats, including the freeze-dried Wharton's jelly and exosome products, are shelf-stable and remove the cold-chain step entirely, which some surgery centers prefer for inventory management.
Confirming regulatory posture with Colorado's medical board
Colorado's medical board and a practice's own healthcare counsel are the appropriate parties to confirm how a specific intended use is classified under federal HCT/P rules. Precision Biologics does not provide clinical guidance, dosing recommendations, or protocol instructions.
Physicians who want a documentation-focused conversation can request a peer-to-peer call before opening an account.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Do you work with ambulatory surgery centers, or only physician offices?+
Both. Any licensed physician-directed practice or surgery center with a valid NPI number can apply for a verified account.
What documentation should we review before adding a product to our vendor list?+
Request the lot's certificate of analysis, the donor eligibility summary, and the sterility testing and release record, and confirm independently that supplier materials make no disease-specific claims.
Who decides if our intended use meets the federal minimal manipulation standard?+
That determination is made by your practice and its counsel under 21 CFR 1271.10, not by Precision Biologics.