FDA Registration
Active
🇺🇸 United States
PACE SURGICAL
Reg #: 3042765769
·
FEI: 3042765769
·
Expires 2026
Products
10
Proprietary Names
2
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- PACE SURGICAL
- Registration Number
- 3042765769
- FEI Number
- 3042765769
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7 Great Valley Pkwy Ste 295
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251555
Owner / Operator
- Firm Name
- Pace Surgical
- Operator Number
- 10094629
- Address
- 7 Great Valley Parkway, Suite 295
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- Kaileen Osisek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-02-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2026-02-03 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-12-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-02-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2026-02-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2026-02-03 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2026-02-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2026-02-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-11 |
Proprietary Names
Pace Surgical Instruments
Ultra Compression Screw System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility