The following data is part of a premarket notification filed by Graham Medical Technologies, L.l.c. with the FDA for Osteowedge Opening Wedge Bone Locking System.
| Device ID | K111326 |
| 510k Number | K111326 |
| Device Name: | OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | GRAHAM MEDICAL TECHNOLOGIES, L.L.C. 611 WEST 5TH STREET, THIRD FLOOR Austin, TX 78701 |
| Contact | Julie Powell |
| Correspondent | Julie Powell GRAHAM MEDICAL TECHNOLOGIES, L.L.C. 611 WEST 5TH STREET, THIRD FLOOR Austin, TX 78701 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M621OW30LBS26MM0 | K111326 | 000 |
| M621OW25LBS10MM0 | K111326 | 000 |
| M621OW25LBS08MM0 | K111326 | 000 |
| M621OW24TT12MM0 | K111326 | 000 |
| M621GM501100 | K111326 | 000 |
| M621GM501080 | K111326 | 000 |
| M621GM501060 | K111326 | 000 |
| M621GM501040 | K111326 | 000 |
| M621GM501020 | K111326 | 000 |
| M621GM501000 | K111326 | 000 |
| M621GM160010 | K111326 | 000 |
| M621GM150040 | K111326 | 000 |
| M621GM150030 | K111326 | 000 |
| M621GM150020 | K111326 | 000 |
| M621OW25LBS12MM0 | K111326 | 000 |
| M621OW25LBS14MM0 | K111326 | 000 |
| M621OW30LBS24MM0 | K111326 | 000 |
| M621OW30LBS22MM0 | K111326 | 000 |
| M621OW30LBS20MM0 | K111326 | 000 |
| M621OW30LBS18MM0 | K111326 | 000 |
| M621OW30LBS16MM0 | K111326 | 000 |
| M621OW30LBS14MM0 | K111326 | 000 |
| M621OW30LBS12MM0 | K111326 | 000 |
| M621OW30LBS10MM0 | K111326 | 000 |
| M621OW30LBS08MM0 | K111326 | 000 |
| M621OW25LBS22MM0 | K111326 | 000 |
| M621OW25LBS20MM0 | K111326 | 000 |
| M621OW25LBS18MM0 | K111326 | 000 |
| M621OW25LBS16MM0 | K111326 | 000 |
| M621GM150010 | K111326 | 000 |