The following data is part of a premarket notification filed by Plus Orthopedics Ag with the FDA for Pigalileo Total Knee Replacement (tkr) System.
| Device ID | K061362 |
| 510k Number | K061362 |
| Device Name: | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Contact | Pamela J Weagraff |
| Correspondent | Pamela J Weagraff PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996063196 | K061362 | 000 |
| 07611996063110 | K061362 | 000 |
| 07611996063127 | K061362 | 000 |
| 07611996063134 | K061362 | 000 |
| 07611996063141 | K061362 | 000 |
| 07611996063158 | K061362 | 000 |
| 07611996063165 | K061362 | 000 |
| 07611996063172 | K061362 | 000 |
| 07611996063189 | K061362 | 000 |
| 07611996063103 | K061362 | 000 |