Orthovita, Inc., dBA Stryker Orthobiologics.

all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch || 2110-0524 Beveled Needle, 11 gauge x 6 inch || 2110-0506 Diamond Needle, 11 gauge x 4 inch || 2110-0529 Diamond Needle, 11 gauge x 6 inch || Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.

all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch || 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch || 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch || 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch || 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch || intended for use to aspirate bone marrow or autologous blood.

Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016

General and Plastic Surgery Devices

3

Yes

Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.

Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Orthopedic Devices

1

No

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Manufacturer Part Number 2090-0502, Lot Number Q1006003

Orthopedic Devices

1

No

USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone