Bone Screw, Bone Tack
510(k) K182881
Bone Screw, Bone Tack is a Class II device made by Osstem Implant Co., Ltd.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Specification
- 510(k) Number
- FDA product code
- DZL
- FDA applicant
- Osstem Implant Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4880
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DZL (Screw, Fixation, Intraosseous).
- OsteoMed 210-0041 by Osteomed Corp.
- OsteoMed 213-0011 by Osteomed Corp.
- Leforte System Bone Screw / GBR System Bone Screw 14-AT-004 by Jeil Medical Corporation
- Leforte System Bone Screw / GBR System Bone Screw 14-AT-003 by Jeil Medical Corporation
- KLS MARTIN DRILL-FREE MMF SCREW by KLS-Martin L.P.
- SCREW, BONE, MAXILLOFACIAL by Tekno-Medical
- MEMFIX SCREWS by W. L. Gore & Associates, Inc.
- 2.5 MM LACTOSORB SCREWS by Biomet, Inc.
- STOMA BONE SCREW by Storz am Mark GmbH
- SMF STAINLESS STEEL BONE SCREWS by Synthes (Usa)