Merced
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
13- Orthopaedic Surgery
- 13
How orthopedic groups qualify a biologics vendor
Orthopedic practices and surgery centers generally add a new biologics supplier only after a documented internal review. That review typically covers entity registration and licensure documentation, a certificate of analysis for the specific lot, a donor eligibility summary, and a lot release record.
Precision Biologics makes this documentation available to verified accounts so a practice's purchasing lead or vendor committee can complete its own qualification process before placing an order.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Entity registration and licensure documentation
Opening an NPI-verified account
Every ordering account is checked against an NPI number in the NPPES registry before it can place an order, which keeps purchasing limited to licensed professionals and the facilities where they practice.
Account setup starts with submitting the practice's NPI and basic facility details. Pricing is shared only with verified accounts, consistent with Precision Biologics' policy of not publishing prices.
Receiving cold-chain shipments in the West region
Cryopreserved products are stored at -80 degrees Celsius and shipped overnight on dry ice in validated containers built to hold temperature in transit to West region addresses, including Merced.
Each shipment is tied to a unique lot identifier, which lets the receiving practice log the product by lot at the patient record level. Staff should plan to inspect and log cold-chain packages on arrival.
Confirming regulatory posture before you order
Whether a specific intended use for a Wharton's jelly or exosome product fits within a practice's regulatory posture is a determination for the practice and its own counsel, not something Precision Biologics advises on.
Practices are encouraged to confirm medical director oversight and scope-of-practice questions with the California medical board and their own legal counsel. Precision Biologics supports account setup through peer-to-peer calls about product documentation, not clinical guidance.
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
Can an orthopedic surgery center in Merced open an account directly with Precision Biologics?+
Yes. Licensed orthopedic practices and surgery centers can apply for an NPI-verified account; orders are limited to licensed professionals and documentation is shared once the account is verified.
What documentation should we request before adding Precision Biologics to our approved vendor list?+
Ask for a certificate of analysis, donor eligibility summary, lot release record, and entity registration and licensure documentation for the lot you intend to order.
Who decides whether a Wharton's jelly product fits a specific orthopedic use under federal rules?+
That determination belongs to the practice and its own regulatory counsel under 21 CFR 1271.10. Precision Biologics does not advise on clinical use, indications, or dosing.