FDA Registration
Active
🇺🇸 United States
IMPACT PRINTING AND DESIGN
Reg #: 3009336009
·
FEI: 3009336009
·
Expires 2026
Products
1
Proprietary Names
52
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- IMPACT PRINTING AND DESIGN
- Registration Number
- 3009336009
- FEI Number
- 3009336009
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4670 Groves Rd
- City
- Columbus
- State
- OH
- ZIP
- 43232
- Country
- US
Owner / Operator
- Firm Name
- Impact Printing and Design
- Operator Number
- 10085178
- Address
- 4670 Groves Rd
- City
- Columbus
- State
- OH
- Postal Code
- 43232
- Country
- US
- Correspondent
- Jonathan D Pitzer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2022-05-17 |
Proprietary Names
97-4501-052-00 TRAB METAL ANKLE 10% XRAY TEMP SET/1
51-200309 Taperloc Complete Microplasty Hip System- STD/High Offset 12/14 Tapers
XR110010239-1 G7 OSSEOTI ACETABULAR SYS REVE 100% ST/4
97-6200-053-00 Trilogy Acetabular System 7mm Offset Template
XR51-102040-4 TAPERLOC COMPLETE R/D XR123 HIP T1 HIP T
97-5026-150-00 Persona Revision Knee System Set of 23, Rev C
XR51-102040-3 TAPERLOC COMPLETE R/D XR123 HIP T1 HIP T
XR51-101050-1 TAPERLOC COMPLETE RD T1 HIP TMPLTS 115%
97-5026-050-00 Persona CR Femoral Components
XRAY000162 G7 Cup Template SET/4
XR010000658-2 G7 ACETABULAR SYSTEM 110% MAG - SET/3
97-502-6052-00 PERSONA PS FEM XRAY TEMPLATE - SET OF 13
XR110010239-2 G7 OSSEOTI ACETABULAR SYS REVE 110% ST/4
XR51-101050-2 TAPERLOC COMPLETE RD T1 HIP TMPLTS 110%
XR154704 Oxford Unicompartmental Knee Sys
XR51-149040-3 TAPERLOC COMPLETE MICRO XR123 T1 HIP TMP
97-7864-050-00 TRABECULAR METAL PRIMARY HIP PROSTHESIS TEMPLATE
XR010000658-3 G7 ACETABULAR SYSTEM 115% MAG SET /3
51-200314 Taperloc Complete XR123 Type 1 / Set of 19
51-200308 Taperloc Complete Microplasty Hip System- STD/High Offset Type 1 Tapers
XR51-102040-2 TAPERLOC COMPLETE R/D XR123 HIP T1 HIP T
XR154701 Oxford Partial High Flex Twin Peg 15%
XR51-101050-3 TAPERLOC COMPLETE RD T1 HIP TMPLTS 100%
51-200300 Taperloc Complete Hip System- STD/High Offset Femoral Component Type 1 Taper / set of 19
97-5026-150-00 PERSONA REV X-RAY TEMPLATES / SET OF 23
XR110010239-3 G7 OSSEOTI ACETABULAR SYS REVE 115% ST/4
154704 Oxford Unicompartmental Knee SYS Set/7
XR010000658-1 G7 ACETABULAR SYSTEM 100% MAG - SET/3
97-5026-051-00 Persona Stemmed Tibial Xray Template Set of 9
51-200303 Taperloc Complete Hip System- STD/High Offset Femoral Component Reduced Distal 12/14 Tapers, set of 18
XR431100 Stageone Cement Spacer Mold Templates / Set of 5
97-5026-052-00 Persona Size 2 CR Femoral Template
51-200312 TAPERLOC COMP MICRO XR 123 TYPE 1
97-5026-051-00 PERSONA STEMMED TIBIAL XRAY TEMPLATE - SET OF 10
XR51-100040-1 TAPERLOC COMPLETE FP T1 HIP 100% ST/19
XRAY000268 TAPERLOC COMPLETE TYPE FULL 15% SET/19
97-6200-151-00 Trilogy Acetabular 15% Template Set of 3
XRAY000270 TAPERLOC COMPLETE XR123 MICRO 15% SET/19
XR431500 Stage One Select Hip / Set of 6
XR51-100040-2 TAPERLOC COMPLETE FP T1 HIP TMPLTS 110%
97-4501-050-00 TRABECULAR METAL TOTAL ANKLE TEMPLATE-1
51-200301 Taperloc Complete Hip System- STD/High Offset Femoral Component 12/14 Taper / set of 19
XRAY000269 TAPERLOC COMPLETE TYPE 1 MICROS SET/19
51-200302 Taperloc Complete Hip System- STD/High Offset Femoral Component Reduced Distal Type 1 Taper, set of 19
154698 Oxford Uni Std Template 15% / Set of 1
XR51-149040-2 TAPERLOC COMPLETE MICRO XR123 T1 HIP TMP
XR51-108040-3 TAPERLOC COMPLETE MICRO T1 HIP TMPLTS 19
97-7255-043-00 Trabecular Metal Acetabular Cup Systems / Set of 3
XRAY000162 G7 CUP TEMPLATE SET/3
Zimmer Biomet Templates
XRAY000256 STAGE ONE SHOULDER SPACER MOLD 20% ST/5
XR110010239-4 G7 OSSEOTI ACETABULAR SYS REVE 120% ST/4
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)