The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Smith & Nephew Hip Arthroscopy Repair Instrument Tray.
| Device ID | K102544 |
| 510k Number | K102544 |
| Device Name: | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Kathleen Solomon |
| Correspondent | Kathleen Solomon SMITH & NEPHEW INC., ENDOSCOPY DIV. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2011-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556686218 | K102544 | 000 |
| 03596010652454 | K102544 | 000 |