K-number	K080547
Device name	ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
Applicant	Aesculap Implant System, Inc.
Product code	HAW
Device class	Class II
Decision date	May 23, 2008
Decision	Substantially Equivalent
Regulation	882.4560

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

Everything you need for a 510(k) submission. Nothing you don't.