The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Plla, Ha Screw.
| Device ID | K080358 |
| 510k Number | K080358 |
| Device Name: | PLLA, HA SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010611871 | K080358 | 000 |
| 03596010611741 | K080358 | 000 |
| 03596010611734 | K080358 | 000 |
| 03596010611727 | K080358 | 000 |
| 03596010611710 | K080358 | 000 |
| 03596010611703 | K080358 | 000 |
| 03596010611697 | K080358 | 000 |
| 03596010611680 | K080358 | 000 |
| 03596010611673 | K080358 | 000 |
| 03596010611666 | K080358 | 000 |
| 03596010611659 | K080358 | 000 |
| 03596010611758 | K080358 | 000 |
| 03596010611765 | K080358 | 000 |
| 03596010611864 | K080358 | 000 |
| 03596010611857 | K080358 | 000 |
| 03596010611840 | K080358 | 000 |
| 03596010611833 | K080358 | 000 |
| 03596010611826 | K080358 | 000 |
| 03596010611819 | K080358 | 000 |
| 03596010611802 | K080358 | 000 |
| 03596010611796 | K080358 | 000 |
| 03596010611789 | K080358 | 000 |
| 03596010611772 | K080358 | 000 |
| 03596010611642 | K080358 | 000 |