INSTRUMENT AND IMPLANT

Solicitation SPE2DS-27-T-1466 is a federal procurement issued by the Department of Defense, specifically the Medical Supply Chain MD Surg FSF, for one orthopedic mini-fragment instrument and implant set under NSN 6515-01-466-7345. The set includes specialized components such as Kirschner wires, a graphic case, drills, a router-quick coupling, chisels, an inserter-extractor, a slotted hammer, and positioning plates. This Class II FDA-regulated device requires 510(k) clearance and must adhere to a non-extendable shelf life of 60 months, with no more than 9 months elapsed from the date of manufacture to the date of delivery. Delivery is required within 20 days after receipt of the order, with the place of performance and delivery designated as FOB Destination at the USNS Comfort MTF. The contract mandates strict adherence to quality and packaging standards, including MIL-STD-2073-1E, special packaging instructions MPPWN00001, and the Medical Marking Standard No. 1. Bidders must specify the source and part number being supplied and are prohibited from using additive manufacturing unless specifically authorized. Administrative requirements include the use of the Wide Area WorkFlow system for electronic invoicing and payment. The procurement is subject to various FAR and DFARS clauses, including the Buy American Act, cybersecurity reporting under DFARS 252.204-7012, and NIST SP 800-171 assessment requirements. Evaluation may include a price preference for HUBZone concerns, and alternate offers must be accompanied by complete technical data to be considered.