FDA Registration
Active
🇺🇸 United States
Haven Manufacturing
Reg #: 1834179
·
FEI: 1000160371
·
Expires 2026
Products
8
Proprietary Names
39
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Haven Manufacturing
- Registration Number
- 1834179
- FEI Number
- 1000160371
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6935 N State Road 1
- City
- OSSIAN
- State
- IN
- ZIP
- 46777
- Country
- US
Owner / Operator
- Firm Name
- CADREX /Haven Manufacturing Indiana
- Operator Number
- 9008697
- Address
- 6935 N. State Road 1
- City
- Ossian
- State
- IN
- Postal Code
- 46777
- Country
- US
- Correspondent
- Leigh Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Impactor | HWA | Class 1 | Orthopedic | No | 2007-11-29 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2018-08-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2026-03-15 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2019-01-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2019-11-04 |
Proprietary Names
NA (00889024197572)
PINNACLE (10603295099093)
NA (00889024197534)
PINNACLE (10603295098966)
PINNACLE (10603295098935)
PINNACLE (10603295098959)
PINNACLE (10603295098973)
DEPUY (10603295084358)
SELF CENTERING (10603295084501)
PERSONA® Zimmer FuZion (00889024232273)
PERSONA® Zimmer FuZion (00889024232259)
DEPUY (10603295084334)
PERSONA® Zimmer FuZion (00889024232266)
DEPUY (10603295084341)
NexGen® Legacy® (00889024226272)
NA (00889024217836)
NexGen® (00889024215887)
NexGen® (00889024215849)
NexGen® (00889024215856)
NexGen® Trabucular Metal® (00889024208179)
NexGen® (00889024201668)
NexGen® (00889024207264)
NA (00889024217843)
NexGen® (00889024215863)
NexGen® (00889024201675)
NexGen® (00889024215825)
NA (00889024217829)
MICRO-MILL® (00889024213777)
NA (00889024212985)
NexGen® (00889024212794)
NexGen® (00889024201644)
NexGen® (00889024216600)
NexGen® (00889024216549)
SUMMIT (10603295143178)
SUMMIT (10603295143185)
AML EXCEL (10603295080008)
AML EXCEL (10603295080015)
AML EXCEL (10603295080022)
Trabecular Metal® (00889024271081)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)