The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Surgicraft Lockdown Acromioclavicular (ac) Device.
| Device ID | K091207 |
| 510k Number | K091207 |
| Device Name: | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE |
| Classification | Washer, Bolt Nut |
| Applicant | SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald W Guthner |
| Correspondent | Donald W Guthner SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-24 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060433600333 | K091207 | 000 |
| 05060433600159 | K091207 | 000 |
| 05060433600142 | K091207 | 000 |
| 05060433600135 | K091207 | 000 |
| 05060433600128 | K091207 | 000 |
| 05060433600111 | K091207 | 000 |
| 05060433600104 | K091207 | 000 |
| 05060433600098 | K091207 | 000 |
| 05060433600081 | K091207 | 000 |
| 05060433600074 | K091207 | 000 |
| 05060433600067 | K091207 | 000 |
| 05060433600050 | K091207 | 000 |
| 05060433600043 | K091207 | 000 |
| 05060433600036 | K091207 | 000 |
| 05060433600029 | K091207 | 000 |
| 05060433600012 | K091207 | 000 |
| 05060433600166 | K091207 | 000 |
| 05060433600173 | K091207 | 000 |
| 05060433600326 | K091207 | 000 |
| 05060433600319 | K091207 | 000 |
| 05060433600302 | K091207 | 000 |
| 05060433600296 | K091207 | 000 |
| 05060433600289 | K091207 | 000 |
| 05060433600272 | K091207 | 000 |
| 05060433600265 | K091207 | 000 |
| 05060433600258 | K091207 | 000 |
| 05060433600241 | K091207 | 000 |
| 05060433600234 | K091207 | 000 |
| 05060433600227 | K091207 | 000 |
| 05060433600210 | K091207 | 000 |
| 05060433600203 | K091207 | 000 |
| 05060433600197 | K091207 | 000 |
| 05060433600180 | K091207 | 000 |
| 05060433600005 | K091207 | 000 |