The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Obl 2.0 Mm Mini Tac Anchor, Model 10-1629-01.
| Device ID | K000797 |
| 510k Number | K000797 |
| Device Name: | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 |
| Classification | Staple, Fixation, Bone |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 15990 N GREENWAY-HAYDEN LOOP SUITE 100 Scottsdale, AZ 85260 |
| Contact | Melody F Martin |
| Correspondent | Melody F Martin ORTHOPAEDIC BIOSYSTEMS, LTD. 15990 N GREENWAY-HAYDEN LOOP SUITE 100 Scottsdale, AZ 85260 |
| Product Code | JDR |
| Subsequent Product Code | GAT |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010533012 | K000797 | 000 |
| 03596010619013 | K000797 | 000 |
| 03596010533029 | K000797 | 000 |