VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P050044/S003 · decided 2007-12-17
Approval details
- PMA number
- P050044
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2007-11-06
- Decision date
- 2007-12-17
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR A CONTRACT TESTING FACILITY LOCATED AT LEXAMED, TOLEDO, OHIO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HipCheck (K230045) | Stryker Corp. | 2023-09-29 |
| Stryker CrossFlow Integrated Arthroscopy Pump (K191259) | Stryker Corp. | 2019-07-12 |
| HipCheck (K182359) | Stryker Corp. | 2018-12-13 |
| Stryker Footed Attachments and Cutting Accessories (K143399) | Stryker Corp. | 2015-05-08 |
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |
| LITe Plate System (K150449) | Stryker Corp. | 2015-03-20 |
| Xia 3 Spinal System (K142381) | Stryker Corp. | 2014-10-21 |
| ICONIX ALL SUTURE ANCHORS (K133671) | Stryker Corp. | 2014-02-28 |