The following data is part of a premarket notification filed by Etex Corp. with the FDA for Cap Plus, Equivabone, Cap/dbm.
| Device ID | K080329 |
| 510k Number | K080329 |
| Device Name: | CAP PLUS, EQUIVABONE, CAP/DBM |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Pamela W Adams |
| Correspondent | Pamela W Adams ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-07 |
| Decision Date | 2008-04-28 |
| Summary: | summary |