Memphis
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
111- Orthopaedic Surgery
- 111
Qualifying a Biologics Vendor for an Orthopedic Practice
Orthopedic groups and ambulatory surgery centers typically start vendor qualification with documentation, not with a sales conversation. That means requesting a certificate of analysis, a donor eligibility summary, and a description of how a lot was tested before it was cleared for release.
Precision Biologics provides this documentation on request to verified accounts so a practice's compliance or quality staff can review it alongside its own 21 CFR 1271.10 analysis before any purchase decision is made.
- Certificate of analysis for the lot
- Donor eligibility summary
- Description of sterility testing and release criteria
NPI-Verified Accounts and Ordering Access
Every account is tied to an NPI number, and ordering access is limited to licensed professionals rather than the general public. This mirrors how most orthopedic practices already structure vendor relationships for other lot-tracked products.
Setting up an account involves confirming the ordering provider's NPI and practice address, after which Precision Biologics assigns account-level access for reordering and documentation requests.
Cold-Chain Shipping to the Memphis Area
Cryopreserved biologics are stored at -80 degrees C and shipped overnight on dry ice in validated containers, a standard that applies to shipments into the Memphis area the same way it applies anywhere else.
Each lot carries a unique identifier so a clinic can log receipt against that lot number and maintain its own patient-level traceability once a product is used.
Confirming Regulatory Posture with the Tennessee Board and Counsel
Whether a specific intended use of a tissue allograft or exosome product fits within section 361 of the Public Health Service Act, or falls under separate biologic drug regulation, is a determination that belongs to the practice and its own legal counsel, not to a supplier.
Practices in Memphis should confirm their own regulatory posture with the Tennessee medical board and qualified counsel before adding any new product category to clinical purchasing. Precision Biologics can provide supporting documentation for that review but does not offer clinical or regulatory advice.
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
Does Precision Biologics have a representative based in Memphis?+
No. Accounts are supported remotely through documentation review and peer-to-peer calls with a physician about product paperwork; there is no local office or sales rep assigned to the Memphis market.
How long does it take to open a new ordering account?+
Account setup depends on NPI verification and the completeness of the information a practice provides, so there is no published standard turnaround; each verification is handled individually.
Can an ambulatory surgery center order directly, or does it need a physician's NPI?+
Ordering accounts are tied to an individual or group NPI held by a licensed professional, so a surgery center would set up its account under that provider's registration rather than a facility-only listing.